BURN- lidocaine hydrochloride gel 
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 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 more 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, Gujarat. 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, Gujarat. India

Made in India

BURN Gel

Galentic

3.5 g packets

6 Per Box

NDC # 50382-020-12

PRINCIPAL DISPLAY PANEL - 3.5 g Packet Carton

BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
IMIDUREA (UNII: M629807ATL)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-020-11144 in 1 CARTON04/01/2018
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:50382-020-126 in 1 CARTON09/07/2017
23.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:50382-020-1325 in 1 CARTON09/07/2017
33.5 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:50382-020-141728 in 1 CARTON09/07/2017
43.5 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 finalpart34809/07/2017
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176analysis(50382-020) , manufacture(50382-020) , pack(50382-020) , sterilize(50382-020)

Revised: 11/2022
 
Galentic Pharma (India) Private Limited