SUAVE HAND SANITIZER- ethyl alcohol gel
UNILEVER ASIA PRIVATE LIMITED

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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Suave HAND SANITIZER (80% ETHYL ALCOHOL)

Active ingredient

Alcohol 80%

Purpose

Antiseptic

Uses

help decrease bacteria on the hands

Warnings

For exteral use only

Flammable. Keep away from fire or flame.

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

If irritation develops, discontinue use and consult a doctor.

Keep out of reach of children except under adult supervision. 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

Aminomethyl Propanol, Carbomer，Denatonium Benzoate, Purified Water USP

01b LBL_Suave 500mL_Sinno

SUAVE HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50069-106(NDC:75497-103)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50069-106-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
2	NDC:50069-106-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/06/2020

Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)