HAND SANITIZER- hand sanitizer gel
Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.

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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Store in cool&dry place

Acrylate / C10-30 Alkyl Acrylate Crosspolymer

Glycerol

Amino acid

Purified Water

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Ethyl Alcoho

keep out of reach of children

Disinfection
Sterilization
No Rinseing

1.For external use only. Keep away from fire or flame.
2.Do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.
3.Stop use and ask a doctor if iritation or rash appears and lasts.
4.Keep out of reach of children.

5.Store in cool&dry place

label

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54586-001
Route of Administration	EXTRACORPOREAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
AMINO ACIDS, ESSENTIAL (UNII: N7U7BXP2OI)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	Score
Shape	Size
Flavor	Imprint Code	ecofinest
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54586-001-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/27/2020

Labeler - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd. (545558488)

Name	Address	ID/FEI	Business Operations
Establishment
Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.		545558488	manufacture(54586-001)