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Standard ANSI First Aid

Dosage form: kit
Ingredients: WATER 991mg in 1mL; BENZALKONIUM CHLORIDE 0.13g in 100g; ISOPROPYL ALCOHOL 70g in 100g; BACITRACIN ZINC 400[iU] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g; BENZALKONIUM CHLORIDE 0.13g in 100g, LIDOCAINE HYDROCHLORIDE 0.5g in 100g; ALCOHOL 0.62g in 1g
Labeler: CMC Group, Inc.
NDC Code: 49687-0020

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.

Standard ANSI First Aid Kit

Drug Facts - Eye Wash (49687-0010-0)

Active ingredient

Purified Water 99.1%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Inactive ingredients

Benzalkonium chloride, sodium chloride

Drug Facts - Antiseptic Towelettes (49687-0016-0)

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

First Aid Antiseptic

Use:

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

Warnings:

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 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.

DRUG FACTS - Alcohol Cleansing Pads (49687-0012-0)

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Purpose:

Antiseptic

Use:

For preparation of the skin before injection.

Warnings:

For external use only.
Flammable - keep away from fire or flame.

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.

Directions:

Wipe injection site vigorously and discard.

Other information:

Store at room temperature 15°-30° C (59°-86° F)

Inactive ingredient:

Purified water.

Drug Facts - Antibiotic Application (49687-0013-0)

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)
Neomycin sulfate (neomycin 3.5mg)
Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only

Do not use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

• deep or punture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area. • Apply a 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.

Inactive ingredients

Mineral oil, petrolatum, purified water

Drug Facts - Burn Treatment (49687-0014-0)

Active ingredients

Benzalkonium chloride 0.13%
Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Warnings

For external use only.

Do not use

• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other information

Store at room temperature

Drug Facts - Hand Sanitizer (49687-0015-0)

Inactive ingredients

glycerin monostearate, glycerol, purified water

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame
For external use only.

Do not use
  • in the eyes.

Stop use and ask a doctor if
  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Eye Wash (49687-0010-0) Labeling:

Antiseptic Towelettes (49687-0016-0) Labeling:

Alcohol Cleansing Pads (49687-0012-0) Labeling:

Antibiotic Application (49687-0013-0) Labeling:

Burn Treatment (49687-0014-0) Labeling:

Hand Sanitizer (49687-0015-0) Labeling:

Standard ANSI First Aid (49687-0020-0) Labeling:

STANDARD ANSI FIRST AID 
water, benzalkonium chloride, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0020
Packaging
#Item CodePackage Description
1NDC:49687-0020-01 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 210 PATCH 9 g
Part 320 PATCH 18 g
Part 46 PACKAGE 5 g
Part 510 PACKAGE 9 g
Part 66 PACKAGE 5.4 g
Part 1 of 6
EYE WASH 
water solution
Product Information
Item Code (Source)NDC:49687-0010
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER991 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:49687-0010-01 TUBE in 1 BOX
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34908/10/2016
Part 2 of 6
ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth
Product Information
Item Code (Source)NDC:49687-0011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:49687-0011-01 BOX in 1 BOX
110 PATCH in 1 BOX
10.9 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2016
Part 3 of 6
ALCOHOL CLEANSING 
isopropyl alcohol cloth
Product Information
Item Code (Source)NDC:49687-0012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:49687-0012-01 BOX in 1 BOX
120 PATCH in 1 BOX
10.9 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2016
Part 4 of 6
ANTIBIOTIC APPLICATION 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:49687-0013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:49687-0013-01 BOX in 1 BOX
110 PACKAGE in 1 BOX
10.9 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/10/2016
Part 5 of 6
BURN TREATMENT 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:49687-0014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:49687-0014-01 BOX in 1 BOX
110 PACKAGE in 1 BOX
10.9 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2016
Part 6 of 6
HAND SANITIZER 
alcohol gel
Product Information
Item Code (Source)NDC:49687-0015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.62 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE 
PROPYLENE GLYCOL 
WATER 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:49687-0015-01 BOX in 1 BOX
16 PACKAGE in 1 BOX
10.9 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33308/10/2016
Labeler - CMC Group, Inc. (005583328)

 
CMC Group, Inc.

Medically reviewed on Dec 23, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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