UNILEVER - Suave HAND SANITIZER (75% ETHYL ALCOHOL), 50069-105, DELIST AS OF 12/31/2022

Suave HAND SANITIZER by

Drug Labeling and Warnings

Suave HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by UNILEVER ASIA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUAVE HAND SANITIZER- 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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UNILEVER - Suave HAND SANITIZER (75% ETHYL ALCOHOL), 50069-105, DELIST AS OF 12/31/2022

Active ingredients

Alcohol 75%

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.

Other information

May discolor fabrics or surfaces. Store below 95°F（35℃）

Inactive ingredients

Water (Aqua), Carbomer，Triethanolamine.

SUAVE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50069-105
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50069-105-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020	12/31/2022
2	NDC: 50069-105-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	12/31/2022
3	NDC: 50069-105-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/06/2020	12/31/2022

Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)

Revised: 1/2022

Document Id: d658799c-eada-8180-e053-2995a90a4e57

34390-5

Set id: e363b00e-39c3-4a07-811e-748177835e19

Version: 9

Effective Time: 20220124