Hand Sanitizer by QUEST USA CORP / Jinhua City Wellmae Cosmetics Co., Ltd. Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by QUEST USA CORP, Jinhua City Wellmae Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer gel 
QUEST USA CORP

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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Hand Sanitizer

ACTIVE INGREDIENT

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For External Use Only. Flammable. Keep Away From Heat Or Flame.

Do not use

ON CHILDREN LESS THAN 2 MONTHS OF AGE

ON OPEN SKIN WOUNDS

When using this product

keep out of ears, eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

Store between 59°-86°F (15°-30℃)

Do not store above 104°F (40℃)

Inactive Ingredients

Water (Aqua) ), Propylene Glycol, Glycerine, Carbopol 940, Aloe Vera Extract, Triethanolamine

Package Label Principal Display Panel

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-012-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/28/2020	12/31/2022

Labeler - QUEST USA CORP (079869689)

Registrant - QUEST USA CORP (079869689)

Establishment
Name	Address	ID/FEI	Business Operations
QUEST USA CORP		079869689	label(78691-012)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua City Wellmae Cosmetics Co., Ltd.		543459963	manufacture(78691-012)

Revised: 12/2022

Document Id: f0e4374b-466b-7384-e053-2a95a90a95bf

34390-5

Set id: a9301b43-bea6-4870-e053-2995a90af937

Version: 3

Effective Time: 20221228