74620-009 HAND SANITIZERT replace 008

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by COSBE LABORA TORY INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer gel 
COSBE LABORA TORY INC.
Reference Label Set Id: adb062c4-22c4-59d9-e053-2995a90ab771

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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74620-009 HAND SANITIZERT replace 008

Active Ingredient

Alcohol 75%v/v

Purpose

Antimicrobial

Use

help decrease bacteia on the hands
Recommended for repeated use

Warnings

Flammable. Keep away from fire or fame. For external use only

/

When using this product

When using this product do not got into eyes. If contact occurs, rinse eyes thoroughly wth water

Stop use and ask a doctor if imitation or rash appears on the skin

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center night away

Directions

Dispense a small amount on palms. Rub ighty until dry, Do not rinse

Other information

store below 110°F(43°C)
may discolour certain fabric or surtaces

Inactive ingredients

acylates/c10-30 alkyl arylate crosspolymer, aloe barbadensis leaf extract, artemisia argyi leaf extract, butylene glycol, cnidIum monnieRI fruit extract, fragrance, glycerin, Sargassum fusiforme extract, triethanolamine, water (aqua)

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74620-009
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
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74620-009-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/29/2020	01/03/2023

Labeler - COSBE LABORA TORY INC. (543033650)

Registrant - COSBE LABORA TORY INC. (543033650)

Establishment
Name	Address	ID/FEI	Business Operations
COSBE LABORA TORY INC.		543033650	manufacture(74620-009)

Revised: 1/2023

Document Id: f156c2f9-5485-a84e-e053-2a95a90a5273

34390-5

Set id: adffbb73-6a40-91d1-e053-2995a90a3576

Version: 3

Effective Time: 20230103