ALOE HAND SANITIZER- alcohol gel

ALOE Hand Sanitizer by

Drug Labeling and Warnings

ALOE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO., LTD., MEGACOS MANUFACTURING Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 62% w/w

INACTIVE INGREDIENT

Water, Glycerin, Carbomer, Triethanolamine, Fragrance, Linalool, Hexyl Cinnamal, Aloe Vera Gel, Witch Hazel Extract, Butylphenyl Methylpropional, Trehalose Hydrate, Sodium Hyaluronate

PURPOSE

Antimicrobial

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Hand gel that kills germs that can potentially cause disease.

Directions

Dispense an appropriate product onto the palm of hands. Rub hands together until dry.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WITCH HAZEL (UNII: 101I4J0U34)
Butylphenyl Methylpropional (UNII: T7540GJV69)
Trehalose (UNII: B8WCK70T7I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-810-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2021

Labeler - TONYMOLY CO., LTD. (688216798)

Registrant - TONYMOLY CO., LTD. (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
MEGACOS MANUFACTURING Co., Ltd.		694745986	manufacture(59078-810)