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 Meijer Distribution, 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 under2 years of age: ask a doctor

inactive ingredients

water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, triethanolamine, benzyl alcohol, phenoxyethanol, blue 1

Adverse Reactions Section

Questions 1-888-593-0593

DIST. BY MEIJER

DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www. meijer.com

747.001/747AB

package label

meijer

Cooling

Aloe Vera Gel

Topical Analgesic Gel

With Lidocaine

and Menthol

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: 41250-747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4.97 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SULISOBENZONE (UNII: 1W6L629B4K)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-747-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/29/2016

Labeler - Meijer Distribution (006959555)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41250-747)