74620-045 ANTI-BACTERIAL HAND SANITIZER

ANTI-BACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

ANTI-BACTERIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by COSBE LABORATORY INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-BACTERIAL HAND SANITIZER- anti-bacterial hand sanitizer gel 
COSBE LABORATORY 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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74620-045
ANTI-BACTERIAL HAND SANITIZER

Active Ingredient(s)

Alcohol 75%V/V.

Purpose

Antiseptic

Use

Use to help reduce bac tera on skin

Warnings

Flammable.Keep away from fire, flame and high heat.
For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product, avoid contact with eyes.If contact occurs, rinse thoroughwater.Avoid

contact wbroken skin.Do not inhale or ingest.

Stop use and ask a doctor if irritation or redness occurs.

Keep out of reach of children and pets.If swallowed, get medical help or contact Poison

Control Center right away.

Directions

Dispense into hand, rub thoroughtidry.

Other information

May discolor certain fabrics or surf ces.
Do not store above 110°F(43°C).

Inactive ingredients

Water(Aqua), Glycerin, Butylene Glycol, Fagance (Parfum) , Acrylates/C10-30 Alkyl Acrylate crosspolymer, Triethanolamine, Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract

Package Label - Principal Display Panel

74620-045-01 236ml

ANTI-BACTERIAL HAND SANITIZER 
anti-bacterial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74620-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74620-045-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	01/03/2023

Labeler - COSBE LABORATORY INC (543033650)

Establishment
Name	Address	ID/FEI	Business Operations
COSBE LABORATORY INC		543033650	manufacture(74620-045)

Revised: 1/2023

Document Id: f154605c-5013-05bb-e053-2995a90a5fc7

34390-5

Set id: c21e077a-98ad-4bce-e053-2995a90a6d07

Version: 2

Effective Time: 20230102