COSMOBEAUTI - HAND SANITIZER GEL (69077-110) - 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 - HAND SANITIZER GEL (69077-110) - DELIST

ACTIVE INGREDIENTS

ETHYL ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE.

FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

• ON CHILDREN LESS THAN 2 MONTHS OF AGE
• ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH.

IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

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

DIRECTIONS

• PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
• SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

OTHER INFORMATION

• STORE BETWEEN 15-30C (59 - 85F)
• AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

INACTIVE INGREDIENTS

ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, AMINOMETHYL PROPANOL, 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: 69077-110
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69077-110-13	375 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020	12/31/2021

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

Revised: 3/2023

Document Id: f67ce46f-fe84-e06f-e053-2a95a90ae28d

34390-5

Set id: 9367cfcc-03a6-4cfc-a20f-7c9f02b9ee96

Version: 3

Effective Time: 20230309

 

COSMOBEAUT