BURN RELIEF ALOE- lidocaine hcl gel

Burn Relief Aloe by

Drug Labeling and Warnings

Burn Relief Aloe by is a Otc medication manufactured, distributed, or labeled by Acutens, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                         Purpose

LIDOCAINE HYDROCHLORIDE               Pain Reliever

PURPOSE

Uses:

For 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.

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

Do not usein large quantities, particularly over raw surfaces or blistered area

Keep out of reach of children.

Direction

adults and children over 2 years and older: Apply to affected area not more than 3-4 times a day

Children under 2 years old: consult a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract
Avena Sativa (Oat) Kernel Extract
Blue 1
Caprylyl Glycol
Chlorphenesin
Dimethyl Isosorbide
Glycerin
Hydroxyethylcellulose
Isopropyl Alcohol
Phenoxyethanol
Polysorbate 20
Propanediol
Tocopheryl Acetate
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF ALOE 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
OAT (UNII: Z6J799EAJK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80551-001-03	113 g in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/18/2021

Labeler - Acutens (051133165)