BURN RELIEF ALOE VERA GEL GNP- lidocaine hl gel

Burn Relief Aloe Vera Gel by

Drug Labeling and Warnings

Burn Relief Aloe Vera Gel by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                 Purpose

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

PURPOSE

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?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF ALOE VERA GEL   GNP
lidocaine hl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-654
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-654-34	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/15/2021

Labeler - Amerisource Bergen (007914906)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(46122-654)