INSTANT HAND SANITIZER GEL 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., 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 skin.

Warnings

High Flammable.

Keep away from fire or flame.

For external use only.

DO NOT USE

When using this product

avoid contact with eyes

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

STOP USE

Keep out of reach of children

Children should use under adult supervision.

Directions

instant hand sanitizer gel kills 99.99% of germs.

use wherever and wherever withoutwater.

squeeze thumbrail size amount in your palm then rub hands until dry.

Other information

Store below 110°F(43°C)

may discolour certain fabrics or surfaces.

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, abe

barbadensis leaf extract, artemisia argyi leaf extract,

butylene glycol, cnidium monnieri fruit extract,fragrance,glycerin,sargassum fusiforme,extract,triethanolamine,water(aqua).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER GEL 
instant hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74620-003
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)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74620-003-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
2	NDC: 74620-003-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
3	NDC: 74620-003-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
4	NDC: 74620-003-04	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
5	NDC: 74620-003-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
6	NDC: 74620-003-06	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
7	NDC: 74620-003-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
8	NDC: 74620-003-08	2188 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/07/2020

Labeler - COSBE LABORA TORY INC. (543033650)

Registrant - COSBE LABORA TORY INC. (543033650)

Establishment
Name	Address	ID/FEI	Business Operations
DOLLAR GENERAL CORPORATION		006946172	label(74620-003)

Establishment
Name	Address	ID/FEI	Business Operations
COSBE LABORA TORY INC.		543033650	manufacture(74620-003)

Establishment
Name	Address	ID/FEI	Business Operations
TAKBO LIMITED		663182517	label(74620-003)