Medication Guide App

GFA First Aid Kit Essentials - 33 Pieces

Dosage form: kit
Ingredients: BACITRACIN ZINC 400[iU] in 1g, NEOMYCIN SULFATE 5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g; IBUPROFEN 200mg; ACETAMINOPHEN 325mg; ISOPROPYL ALCOHOL 70mL in 100mL; ASPIRIN 325mg; BENZALKONIUM CHLORIDE 0.40mL in 100mL
Labeler: Genuine First Aid, LLC
NDC Code: 52124-1023

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Genuine First Aid - FIRST AID KIT Essentials 33 Pieces

Active Ingredient: .........Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

Uses:  To help prevent infection in:
minor cuts;  scrapes;  burns

Warnings:

For external use only.

Do not use:  in eyes;  over large areas of the body;

If allergic to any of the ingredients;  for more than one week unless directed by a physician.

Stop use and consult a doctor:

if the condition persists or gets worse;  a rash or other allergic reaction develops

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

Other information:

Store at room temperature.

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

 Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.


Active ingredient (in each tablet)                       Purpose

Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug


Uses temporarily relieves minor aches and pains due to:

the common cold

headache

toothache

muscular aches

backache

minor pain of arthritis

menstrual cramps temporarily reduces fever



Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach
bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed


Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic


Ask a doctor before use if you are:
taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

When using this product:
take with food or milk if stomach upset occurs

Stop use and ask a doctor If:
you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:
do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.



Other information:  Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

IBUPROFEN 2 Tablets

IBUPROFEN   2 Tablets

Active Ingredient (in each tablet)                      Purpose

Aspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer

*nonsteroidal anti-inflammatory drug 

Uses   Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

Warnings

Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:   Aspirin may cause a severe allergic reaction which may include:  hives, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:   This contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:
are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed

Do not use:  if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

Ask a doctor before use if: stomach bleeding warning applies to you;  you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

under a doctor's care for any serious condition;  taking any other drug

When using this product: take with food or milk if stomach upset occurs


Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
feel faint;  vomit blood; have bloody or black stools; have stomach
pain that does not get better; pain gets worse or lasts more than 10 days;  fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.  In case of overdose, get medical help or

contact a Poison Control Center right away.

Directions

do not use more than directed

the smallest effective dose should be used

drink a full glass of water with each dose

do not take longer than 10 days, unless directed by a doctor


Adults and children: (12 years and older) Take 1 or 2 tablets with

water every 4 hours as needed.  Do not take more than 12 tablets in 24

hours, or as directed by a doctor.

Children under 12 years:   Do not give to children under 12 years of age.

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); avoid

excessive heat and humidity;  tamper evident sealed packets;

Do not use any opened or torn packets

Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

Distributed by GENUINE FIRST AID
600 Clevelad Str Suite 400, Clearwater, FL 33755

ASPIRIN 2 Tablets

Active Ingredient:                                 Purpose

Benzalkonium Chloride 0.40%..........   First Aid Antiseptic

Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warning:   For external use only.

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Do not use in the eyes or over large areas of the body.

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


Inactive Ingredient:   Purified water


LOT/EXP:                           Made in CHINA

20130301

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Active Ingredient (in each tablet)

Acetaminophen 325 mg

PurposeAnalgesic/antipyretic

Uses


temporary relief of minor aches and pains associated with:

common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever

Warnings

Liver warning:   This product contains acetaminophen.

Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist;  for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt
medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.  Do not exceed recommended dosage

Inactive Ingredients

Cornstarch, polyethylene glycol, stearic acid, povidone

Directions

Adults and Children                        Take 2 tablets every 4 to 6 hours as

12 years of age                               needed.  Do not take more than 12 tablets

or older                                          in 24 hours.



Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

of age                                               needed.  Do not take more than 5

                                                        tablets in 24 hours.



Children under 6                                Do not use this regular strength product.

years of age                                      This will provide more than the

                                                         recommended dose (overdose) and could

                                                         cause serious health problems.

Store at 59-86 degree F (15-30 degree C)


tamper evident sealed packets; do not use any open or torn packets

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

GENUINE FIRST AID         2 Tablets

NON-ASPIRIN

Active Ingredient

Active Ingredient:                                

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

 For preparation of skin before injection.

Warnings

 For external use only.  

Flammable - keep away from fire or flame

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Do not use: with electrocautery, in the eyes.

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Keep out of reach of children.  If swallowed,

get medical help or contact a Poison Control

Center right away.

DirectionsWipe Injection site vigorously and discard.

Inactive Ingredient

Purified water.

LOT/EXP:            Made in CHINA

20140301

Alcohol Cleansing Pad

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID




100 Alcohol cleansing pads

Reorder GFAP-39-02

GFA FIRST AID KIT ESSENTIALS - 33 PIECES 
aspirin, ibuprofen, acetaminophen, alcohol, benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-1023
Packaging
#Item CodePackage Description
1NDC:52124-1023-61 KIT (KIT) in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 TUBE 1 g
Part 22 PACKET
Part 32 PACKAGE
Part 43 PACKAGE 1.5 mL
Part 52 PACKAGE
Part 63 PACKAGE 2.4 mL
Part 1 of 6
GENUINE TRIPLE ANTIBIOTIC 
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:52124-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0003-1.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/18/2011
Part 2 of 6
IBUPROFEN 
ibuprofen tablet
Product Information
Item Code (Source)NDC:52124-0009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE 
STARCH, CORN 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;352
Contains    
Packaging
#Item CodePackage Description
1NDC:52124-0009-12 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501008/18/2011
Part 3 of 6
NON-ASPIRIN  
acetaminophen tablet
Product Information
Item Code (Source)NDC:52124-0010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POLYETHYLENE GLYCOL 
STEARIC ACID 
POVIDONE 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAZ;234
Contains    
Packaging
#Item CodePackage Description
1NDC:52124-0010-12 TABLET (TABLET) in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/18/2011
Part 4 of 6
ALCOHOL CLEANSING PAD 
isopropyl alcohol liquid
Product Information
Item Code (Source)NDC:52124-0002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0002-10.5 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/18/2011
Part 5 of 6
ASPIRIN 
aspirin tablet
Product Information
Item Code (Source)NDC:52124-0011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
STARCH, CORN 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;157;ASPIRIN
Contains    
Packaging
#Item CodePackage Description
1NDC:52124-0011-12 TABLET (TABLET) in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/18/2011
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride swab
Product Information
Item Code (Source)NDC:52124-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.40 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0001-10.8 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E09/09/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333B08/18/2011
Labeler - Genuine First Aid, LLC (619609857)
Registrant - GFA Production (Xiamen) Co., Ltd. (421256261)
Establishment
NameAddressID/FEIOperations
GFA Production (Xiamen) Co., Ltd.421256261manufacture

Revised: 08/2011
 
Genuine First Aid, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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