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Burn by Galentic Pharma (India) Private Limited

Medically reviewed on December 29, 2017

Dosage form: cream
Ingredients: Lidocaine Hydrochloride 5mg in 1g, Benzalkonium Chloride 1.3mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-022

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.

Burn Cream

Drug Facts

• ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

• PURPOSE

Topical antiseptic

Topical analgesic

• USES
  • For temporary relief of pain and itching associated with:
    • sunburn
    • minor burns
    • insect bites
    • minor skin irritation
    • cuts
    • scrapes

• WARNINGS

For external use only.

  • 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

  • Stop use and ask a doctor if
    • the condition gets worse
    • condition clears up and recurs within a few days
    • condition persists for more than 7 days
    • if pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children.

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

• DIRECTIONS

Adults and children 2 years and over:

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

Children under 2 years

  • consult a doctor

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

• INACTIVE INGREDIENTS

Butylated hydroxytoluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Sodium EDTA, Sodium methylparaben, Sodium propylparaben, Purified Water

Manufactured by :
Galentic Pharma (India) Pvt. Ltd.,
Plot No. 5-B & 5-C, Sector III,
Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 0.9 gram Packet Carton

NDC # 50382-022-12

GALENTIC
Burn Cream with Lidocaine

Antiseptic and pain relieving cream
for minor cuts, scrapes and burns

0.9 gram Packets
25 per box

BURN 
lidocaine hydrochloride and benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous5 mg  in 1 g
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene 
Ceteth-20 
Cetostearyl alcohol 
Dimethicone 
Glycerin 
Glyceryl Monostearate 
Isopropyl myristate 
Methylcellulose (25 MPA.S) 
Water 
Edetate Sodium 
methylparaben sodium 
propylparaben sodium 
Packaging
#Item CodePackage Description
1NDC:50382-022-1110 PACKET in 1 CARTON
10.9 g in 1 PACKET
2NDC:50382-022-1225 PACKET in 1 CARTON
20.9 g in 1 PACKET
3NDC:50382-022-13144 PACKET in 1 CARTON
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/01/2015
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-022), MANUFACTURE(50382-022), PACK(50382-022), REPACK(50382-022), STERILIZE(50382-022)

 
Galentic Pharma (India) Private Limited

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Further information

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

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