74620-016 INSTANT HAND SANITIZER GEL

INSTANT HAND SANITIZER Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

INSTANT HAND SANITIZER GEL- instant hand sanitizer gel gel 
COSBE LABORA TORY 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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74620-016
INSTANT HAND SANITIZER GEL

Active Ingredient

Alcohol 75%v/v

Purpose

Antiseptic

Use

Use hand sanitizer to help reduce bacteria on the skin

Warnings

Highly flammable.
Keep away from fire or flame.
For external use only

Keep out of reach of children
if swallowed, get medical help or conta1ct a Poison Control Center ri1ght away
children should use under adult supervision.

When using this product
avoid contact with eyes
In case of contact witih eyes or mouth, rinse with plenty of water and se1ekm edical advice.

/

When using this product

Keep out of reach of children
if swallowed, get medical help or conta1ct a Poison Control Center right away
children should use under adult supervision.

When using this product
avoid contact with eyes
In case of contact witih eyes or mouth, rinse with plenty of water and seek medical advice.

/

Keep out of reach of children

Keep out of reach of children
if swallowed, get medical help or conta1ct a Poison Control Center right away
children should use under adult supervision.

Directions

use wh1erever and whenever without water
pump thumlbnail size amount in your palm then rub hands until dry.

Other information

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

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf extract, artemisia argyi leaf extract, butyle1ne glycol, cnidium monnieri fruit extract, fragrance, glycerin, sargassum fusifonme extract, triethanolamine, water (aqua).

INSTANT HAND SANITIZER GEL 
instant hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74620-016
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: 74620-016-01	500 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(74620-016)

Revised: 1/2023

Document Id: f156a712-b820-6cf5-e053-2995a90a1332

34390-5

Set id: afe4f31e-9ae5-aa55-e053-2a95a90aa1fa

Version: 4

Effective Time: 20230103