Hand Sanitizer by QUEST USA CORP Hand Sanitizer

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, Triethanolamine

Package Label Principal Display Panel

118 ml label

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-011
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78691-011-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020	12/31/2022

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

Labeler - QUEST USA CORP (079869689)

Registrant - QUEST USA CORP (079869689)

Name	Address	ID/FEI	Business Operations
Establishment
QUEST USA CORP		079869689	manufacture(78691-011)

Revised: 12/2022

Document Id: f0d128f5-fcda-0232-e053-2a95a90a714f

Set id: a9275533-72bf-3afe-e053-2a95a90a848d

Version: 2

Effective Time: 20221227

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10