COSMOBEAUTI - HAND SANITIZER GEL - 70% IPA (69077-107) - 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- isopropyl 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 - 70% IPA (69077-107) - DELIST

ACTIVE INGREDIENTS

ISOPROPYL ALCOHOL 70% v/v

PURPOSE

ANTISEPTIC

USES

• Hand sanitizer to help reduce bacteria on the skin
• Recommended for repeated use.

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

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 medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl propanol Taurate, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopherol Acetate (Vitamin E), Water (Aqua).

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69077-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69077-107-02	60 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: f67cae28-cd3d-7936-e053-2a95a90ae923

34390-5

Set id: 9a96fcae-7d9f-47f5-a820-d683552b6a60

Version: 5

Effective Time: 20230309

 

COSMOBEAUT