COSMOBEAUTI - HAND SANITIZER GE (69077-106) - 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.

----------

COSMOBEAUTI - HAND SANITIZER GE (69077-106) - DELIST

ACTIVE INGREDIENTS

ETHYL ALCOHOL 62.5%

PURPOSE

ANTISEPTIC

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOOUT WIPING.

USES

FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

• For external use only-hands.
• Flammable. Keep away from heat and flame. Do not store above 105°F.
• Keep out of eyes.
• Avoid contact with broken skin.
• Do not ingest or inhale.

• Keep out of reach of children. For children under 6, use only under adult supervision.
• In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INACTIVE INGREDIENTS

WATER (AQUA), CARBOMER, DISODIUM EDTA, ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, GLYCERIN, PROPYLENE GLYCOL, FRAGRANCE, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69077-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.5 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: 69077-106-12	375 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/27/2020	12/31/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.		021687376	manufacture(69077-106)

Revised: 3/2023

Document Id: f67cdf39-0d7d-6cce-e053-2995a90af926

34390-5

Set id: 48e6491a-4213-419c-9572-d9a21e06b2a3

Version: 3

Effective Time: 20230309

 

COSMOBEAUT