75% ETHANOL INSTANT HAND SANITIZER GEL gel

75% Ethanol Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

75% Ethanol Instant Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by COSBE LABORA TORY INC., DOLLAR GENERAL CORPORATION, TAKBO LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antimicrobial

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. There may be signs of a serious condition

When using this product

avoid contact with eyes. In case of contact with eyes or mouth. rinse with plenty of water and seek medical advice.

DO NOT USE

Directions

instant hand sanitizer gel kills 99.99% of germs. use wherever and whenever with out water. squeeze thumbnail size amount in your palm then rub hands until dry. Children should use under adult supervision.

Other information

Store below 110°F(43°C)

may discolour certain fabrics or surfaces.

Inactive ingredients

acrylates/ 10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf extract, artemisia argyi leaf extract,butylene glycol, carbomer, cnidium monnieri fruit extract, fragrance, glycerin, sargassum fusiforme extract, triethanolamine, water(aqua)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

75% ETHANOL INSTANT HAND SANITIZER GEL 
75% ethanol instant hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74620-501
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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74620-501-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
2	NDC: 74620-501-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
3	NDC: 74620-501-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
4	NDC: 74620-501-04	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
5	NDC: 74620-501-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
6	NDC: 74620-501-06	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
7	NDC: 74620-501-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
8	NDC: 74620-501-08	2188 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/16/2020

Labeler - COSBE LABORA TORY INC. (543033650)

Registrant - COSBE LABORA TORY INC. (543033650)

Establishment
Name	Address	ID/FEI	Business Operations
DOLLAR GENERAL CORPORATION		006946172	label(74620-501)

Establishment
Name	Address	ID/FEI	Business Operations
COSBE LABORA TORY INC.		543033650	manufacture(74620-501)

Establishment
Name	Address	ID/FEI	Business Operations
TAKBO LIMITED		663182517	label(74620-501)