REDICARE BURN GEL- redicare burn gel gel 
Redicare LLC

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 USA

Active Ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water.

Stop use and ask doctor

if condition worsens or persists for more than 7 days or clears up and occurs 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

Inactive Ingredients

REDICARE

BURN GEL

for minor burns, scalds & sunburn

WITH ALOE VERA FOR BEST RELIEF

3.5g / 1/8 oz.

NDC 71105-500-01

DRUG FACTS...

Packet

REDICARE BURN GEL 
redicare burn gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-500
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
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MENTHOL (UNII: L7T10EIP3A)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71105-500-0215 in 1 BOX10/09/2019
1NDC:71105-500-013.3 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/09/2019
Labeler - Redicare LLC (800149346)

Revised: 10/2019
Document Id: 947ac362-acfc-3508-e053-2a95a90a2873
Set id: 947ac362-acfb-3508-e053-2a95a90a2873
Version: 1
Effective Time: 20191009
 
Redicare LLC