79977-001_ALOE HAND SANITIZER

ALOE HAND SANITIZER by

Drug Labeling and Warnings

ALOE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by UNIVERA CO.,LTD., Greencos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALOE HAND SANITIZER- alcohol gel 
UNIVERA CO.,LTD.

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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79977-001_ALOE HAND SANITIZER

Ethyl Alcohol 62%

Water, Propylene Glycol, Hydroxypropyl Methylcellulose, Carbopol 1342, Triethanolamine, Glycerin, Aloe Vera Gel, Sage Extract, Fragrance, Limonene

Antimicrobial

KEEP OUT OF REACH OF THE CHILDREN

Hand Sanitizer to help reduce bacteria on the skin

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

ALOE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79977-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLARY SAGE (UNII: U3HSK5JC0Q)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79977-001-02	1 in 1 CARTON	08/13/2020	06/03/2021
1	NDC: 79977-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/13/2020	06/03/2021

Labeler - UNIVERA CO.,LTD. (688839203)

Registrant - UNIVERA CO.,LTD. (688839203)

Establishment
Name	Address	ID/FEI	Business Operations
Greencos Co., Ltd.		694777325	manufacture(79977-001)

Revised: 6/2021

Document Id: c3eb4b05-1cc8-9cf1-e053-2a95a90aa531

34390-5

Set id: 6dda9ce3-099d-411a-9e46-ca57dc49fd93

Version: 2

Effective Time: 20210604