SUAVE HAND SANITIZER- alcohol gel
Guangdong Essence Daily Chemical 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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Drug Facts

Active ingredient

Alcohol 75% v/v

purpose

antiseptic

Use

help decrease bacteria on the hands

Warnings

For external use only.

Flammable, Keep away from fire or flame.

Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately.

If irritationdevelops，Discontinue use and consult a doctor.

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

Inactive ingredients

Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

Other information

May discolor fabrics or urfaces.
Store below 95℉ (35℃).

Packaging

image description

SUAVE HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73931-018
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73931-018-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/27/2020

Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)

Name	Address	ID/FEI	Business Operations
Establishment
Guangdong Essence Daily Chemical Co., Ltd		529796211	manufacture(73931-018)