SUAVE HAND SANITIZER PROFESSIONAL- 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 Professional - 75% Ethyl Alcohol

ACTIVE INGREDIENT

Alcohol (75% v/v)

PURPOSE

ANTISEPTIC

USE

Help decrease bacteria on the hands. For use when soap and water are not available.

WARNINGS

For external use only.

Flammable. Keep away from fire or flame. Do not store in car.

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.

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

Do not use:

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Carbomer, Denatonium Benzoate, Purified Water USP, Tert-butyl Alcohol, Triethanolamine.

01b LBL_Suave_Hand Sani Gel_75pct_236mL

01b LBL_Suave_Hand Sani Gel_75pct_500mL

01b LBL_Suave_Hand Sani Gel_75pct_1000mL

SUAVE HAND SANITIZER PROFESSIONAL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50069-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50069-109-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
2NDC:50069-109-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
3NDC:50069-109-13236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/25/2020
Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)

Revised: 11/2020
Document Id: 6a6d1b7a-bff4-4d63-ad6c-2c4d833503ff
Set id: ce6eaf4f-f9d8-433d-b682-01789f3e2f00
Version: 3
Effective Time: 20201123
 
UNILEVER ASIA PRIVATE LIMITED