Hand Sanitizer by Zhejiang Gafle Auto Chemical Co., Ltd. HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Gafle Auto Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on skin

WARNINGS

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

DO NOT USE

When using this product

do not use in near the eyes. In case of contact, rinse eye thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

KEEP OUT OF REACH OF CHILDREN

Directions

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store below 106° F.(41C°)

Inactive ingredients

Purified water, Glycerin, Triethanolamine, Carbomer, Vitamin E

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74763-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74763-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
2	NDC: 74763-001-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
3	NDC: 74763-001-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
4	NDC: 74763-001-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
5	NDC: 74763-001-05	1000 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 - Zhejiang Gafle Auto Chemical Co., Ltd. (550707836)

Registrant - Zhejiang Gafle Auto Chemical Co., Ltd. (550707836)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Gafle Auto Chemical Co., Ltd.		550707836	manufacture(74763-001)