QC BURN RELIEF ALOE- lidocaine hcl gel 
Chain Drug Marketing Association Inc

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 Relief, Lidocaine HCl 0.5%

Lidocaine HCl 0.5%

External Analgesic.

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

For external use only.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician.

Water, Glycerin, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

Label

QC BURN RELIEF ALOE 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-095-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/04/2020
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 1/2023
Document Id: f1d7ed0a-7c63-5091-e053-2a95a90ab7c3
Set id: b5e76f0c-0bfe-b13e-e053-2995a90a0861
Version: 2
Effective Time: 20230109
 
Chain Drug Marketing Association Inc