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Burn by Galentic Pharma (India) Private Limited

Medically reviewed on December 29, 2017

Dosage form: gel
Ingredients: Lidocaine Hydrochloride 20mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-020

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 Gel

• ACTIVE INGREDIENT

Lidocaine Hydrochloride2%

• PURPOSE

Analgesic

• USES
  • For temporary relief of pain and itching associated with:
    • sunburn
    • minor burns
    • Provides cooling pain relief

• WARNINGS

For external use only.

• Do not use
  • On wounds or damaged skin
  • In large quantities, particularly over raw surfaces or blistered areas.

• When using this product
  • Avoid contact with the eyes
  • Do not bandage tightly

• Stop use and ask a doctor if
  • the condition gets worse
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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:

  • Apply to affected area not ore than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor

• OTHER INFORMATION
  • store at room temperature

• INACTIVE INGREDIENTS

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

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 - 3.5 g Packet Carton

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

Made in India

BURN Gel

Galentic

3.5 g packets
6 Per Box
NDC # 50382-020-12

BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride Anhydrous20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERIN 
Propylene Glycol 
IMIDUREA 
TROLAMINE 
WATER 
Methylparaben 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:50382-020-11144 PACKET in 1 CARTON
10.9 g in 1 PACKET
2NDC:50382-020-126 PACKET in 1 CARTON
23.5 g in 1 PACKET
3NDC:50382-020-1325 PACKET in 1 CARTON
33.5 g in 1 PACKET
4NDC:50382-020-141728 PACKET in 1 CARTON
43.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/07/2017
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-020), MANUFACTURE(50382-020), PACK(50382-020), REPACK(50382-020), STERILIZE(50382-020)

 
Galentic Pharma (India) Private Limited

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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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