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Top Safety First Aid Burn Cream

Medically reviewed on May 16, 2018

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 0.5g in 100g, BENZALKONIUM CHLORIDE 0.13g in 100g
Labeler: Top Safety Products Company Inc
NDC Code: 51395-412

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.

Top Safety First Aid Burn Cream

Active Ingredients

Active Ingredient                                       Purpose

Lidocaine HCL 0.5%                                   Topical Analgesic

Benzalkonium Chloride 0.13%                    Topical Antiseptic

Purpose

Temporary relief of pain and itching.

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts and 
  • Scrapes

Warnings

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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

Stop Use

Stop Use and ask a doctor:

  • If condition worsens or,
  • if symptoms persist for more than 7 days or clear up and occur again in a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Do Not Use

Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor

Inactive ingredients

Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

Other Information

Other Information

  • store in a cool, dry area
  • 59o to 79o F (15o to 25o C)
  • Tamper evident sealed packets do not use any open or torn packets

Principal Display Panel

Top Safety First Aid Burn Cream

Top Safety.jpg

TOP SAFETY FIRST AID BURN CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51395-412
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
METHYLCELLULOSE (25 MPA.S) 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
DIMETHICONE 
CETETH-20 
BUTYLATED HYDROXYTOLUENE 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
GLYCERIN 
EDETATE SODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:51395-412-012000 PACKET in 1 BOX
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/07/2016
Labeler - Top Safety Products Company Inc (627999956)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Pvt. Ltd.650970176manufacture(51395-412)

 
Top Safety Products Company Inc

Further information

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

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