BURN RELIEF ALOE VERA GEL  GNP- lidocaine hl gel 
Amerisource Bergen

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 Relief Aloe Gel [GNP]

Active ingredients                                 Purpose

Lidocaine Hydrochloride 0.5% ............. External Analgesic

Uses

For the temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Warnings
For external use only.


When using this product: • avoid contact with eyes. Rinse with water if contact occurs.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask doctor if • symptoms persist for more than 7 days, or 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 immediately.

Directions


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

Inactive ingredients

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

Questions or comments?

888-793-8450

image description

BURN RELIEF ALOE VERA GEL   GNP
lidocaine hl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-654
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-654-34237 mL in 1 CONTAINER; Type 0: Not a Combination Product01/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2021
Labeler - Amerisource Bergen (007914906)
Registrant - Inspec Solutions LLC (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(46122-654)

Revised: 1/2022
Document Id: d5cab181-c104-c95c-e053-2995a90a0708
Set id: a98a9a80-227c-45bf-8004-44575006db2f
Version: 3
Effective Time: 20220117
 
Amerisource Bergen