BURN RELIEF ALOE- lidocaine hcl gel
Acutens

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 Aloe Gel

Active ingredients Purpose

LIDOCAINE HYDROCHLORIDE Pain Reliever

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 use in 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

image description

BURN RELIEF ALOE
lidocaine hcl gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/18/2021

Labeler - Acutens (051133165)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions		081030372	manufacture(80551-001)

Revised: 3/2021

Document Id: be484efa-ff4e-15a9-e053-2995a90a059f

Set id: 48c435fe-2670-4b80-bf01-923dc9354422

Version: 3

Effective Time: 20210324

Acutens