ALOE VERA GEL- lidocaine hcl, menthol gel

Aloe Vera Gel by

Drug Labeling and Warnings

Aloe Vera Gel by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 0.7%

Menthol 0.2%

Purpose

topical analgesic

Uses

for the temporary relief of pain and itching associated with

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations

Warnings

For external use only

When using this product

avoid contact with the eyes

do not use

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens, or 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 right away

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

inactive ingredients

water, alcohol, glycerin, polysorbate 80, carbomer, Aloe barbadensis leaf juice, benzophenone-4, triethanolamine, imidazolidinyl urea, blue 1

claims

Made in the USA

with US and foreign parts

Adverse Reactions Section

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments?

1-888-593-0593

747.001/747AB

principal display panel

mountain

falls

cools &

soothes

with

lidocaine

& menthol

relieving

after sun

aloe gel

topical analgesic

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

ALOE VERA GEL 
lidocaine hcl, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	7 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
TROLAMINE (UNII: 9O3K93S3TK)
IMIDUREA (UNII: M629807ATL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-747-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/24/2017

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11344-747)