Suave HAND SANITIZER (80% ETHYL ALCOHOL)

Suave HAND SANITIZER by

Drug Labeling and Warnings

Suave HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Zhongshan Sinno Cosmetic Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUAVE HAND SANITIZER- ethyl alcohol gel 
Zhongshan Sinno Cosmetic 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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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.

Other information

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

Inactive ingredients

Aminomethyl Propanol, Carbomer, Denatonium Benzoate, Purified Water USP

01b LBL_Suave 500mL_Sinno

SUAVE HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75497-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75497-103-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
2NDC: 75497-103-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/06/2020
Labeler - Zhongshan Sinno Cosmetic Co.,Ltd. (543048039)

Revised: 6/2020
Document Id: 153c6c74-2bf4-49b1-b57d-f1c025f69e6d
Set id: e07b8aef-7a90-4b3c-8826-6a1e490c6795
Version: 1
Effective Time: 20200618