ANTIBACTERIAL HAND SANITIZER- antibacterial hand sanitizer gel
Shanghai Rayshine ENVI-TECH Developing CO., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Antibacterial Hand Sanitizer

Active Ingredients

Glutaraldehyde 0.3%, AES 7.0%, APG 1.0%, AEO-9 0.5%, CAB 3.8%

Purpose

Antibacterial

Uses

For hand sanitizing to reduce bacteria on the skin.

Warnings

For extermal use only-hands. Flamable. Keep aways from heat and flame.

Do not use

in children less than 2 months of ageon open skin wounds

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Inactive Ingredients

Water, Salt, Citric Acid

Package Label - Principal Display Panel

ANTIBACTERIAL HAND SANITIZER
antibacterial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75129-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLUTARAL (UNII: T3C89M417N) (GLUTARAL - UNII:T3C89M417N)	GLUTARAL	0.3 g in 100 mL
CARBONIC ANHYDRASE 1 (UNII: 31F7ZV0E20) (CARBONIC ANHYDRASE 1 - UNII:31F7ZV0E20)	CARBONIC ANHYDRASE 1	3.8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75129-002-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
2	NDC:75129-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
3	NDC:75129-002-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020
4	NDC:75129-002-04	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/18/2020

Labeler - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)

Registrant - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Rayshine ENVI-TECH Developing CO., Ltd.		420836386	manufacture(75129-002)