HAND SANITIZER- alcohol liquid
NINGBO JIANGBEI OCEAN STAR TRADING 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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Active Ingredients

Active ingredients--------------purpose

Ethyl Alcohol 62%------------antiseptic

Uses:
Reduces bacteria on the skin. Recommended for repeated use.

Warnings:

For external use only.Flammable:Keep away from heat for flame.Do no use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Directions:

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

Other Information

Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.

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

Inactive Ingredients:

Water,Glycerin,Isopropyl Myristate, Propylene Glycol,Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47993-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	19.5 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	5 g in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5 g in 100 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	8 g in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.2 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.2 g in 100 g
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47993-200-03	237 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/31/2014	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/03/2014	11/01/2018

Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Name	Address	ID/FEI	Business Operations
Establishment
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD		544493972	manufacture(47993-200)

Revised: 11/2018

Document Id: 7a22268a-2dc5-0f0d-e053-2991aa0a023a

Set id: 5db674c0-ea36-458d-975c-acc0de9546a7

Version: 2

Effective Time: 20181108

NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD