COSMOBEAUTI - SILKEN HAND SANITIZER GEL - 70% ETHYL ALCOHOL (69077-111) - DELIST

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.

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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COSMOBEAUTI - SILKEN HAND SANITIZER GEL - 70% ETHYL ALCOHOL (69077-111) - DELIST

ACTIVE INGREDIENTS

ETHYL ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USES

• FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.
• RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY: HANDS.

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT: KEEP OUT OF EYES

IN CASE OF CONTACT WITH EYE, FLUSH THOROUGHLY WITH WATER.

STOP USE AND CONSULT WITH YOUR DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND/OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDIAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, AMINOMETHYL PROPANOL, AMMONIUM POLYACRYLOYLDIMETHYL TAURATE, CARBOMER, DISODIUM EDTA, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, WATER (AQUA)

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69077-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69077-111-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/12/2020	12/31/2021

Labeler - COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. (021687376)

Revised: 3/2023

Document Id: f67cd2c6-3118-6509-e053-2a95a90a3788

34390-5

Set id: a3cfd66a-f2f8-4941-a720-ed90c130fdfd

Version: 3

Effective Time: 20230309

 

COSMOBEAUT