Burn Cream

Burn Cream

Drug Labeling and Warnings

Drug Details

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BURN- lidocaine hydrochloride and benzalkonium chloride cream 
Galentic Pharma (India) Private Limited

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.

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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

Principal Display Panel - 0.9 gram Packet Carton
BURN 
lidocaine hydrochloride and benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous5 mg  in 1 g
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Ceteth-20 (UNII: I835H2IHHX)  
Cetostearyl alcohol (UNII: 2DMT128M1S)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Isopropyl myristate (UNII: 0RE8K4LNJS)  
Methylcellulose (25 MPA.S) (UNII: BI55GG2WLI)  
Water (UNII: 059QF0KO0R)  
Edetate Sodium (UNII: MP1J8420LU)  
methylparaben sodium (UNII: CR6K9C2NHK)  
propylparaben sodium (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-022-1110 in 1 CARTON04/14/2016
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 50382-022-1225 in 1 CARTON04/14/2016
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC: 50382-022-13144 in 1 CARTON09/01/2015
30.9 g in 1 PACKET; Type 0: Not a Combination Product
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/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-022) , MANUFACTURE(50382-022) , PACK(50382-022) , REPACK(50382-022) , STERILIZE(50382-022)

Revised: 12/2017
 
Galentic Pharma (India) Private Limited


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