ALCOHOL FREE HAND SANITIZER- alcohol free hand sanitizer 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.

----------

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

image of 1oz

ALCOHOL FREE HAND SANITIZER
alcohol free hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47993-230
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	96.4501 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g in 100 g
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)	0.5 g in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.2 g in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E)	0.2 g in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.05 g in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 g in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.15 g in 100 g
AROMADENDRIN (UNII: 7YA4640575)	0.03 g in 100 g
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)	0.0075 g in 100 g
CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)	0.009 g in 100 g
BENZYL SALICYLATE (UNII: WAO5MNK9TU)	0.00162 g in 100 g
3,7-DIMETHYL-1-OCTANOL (UNII: DPY9K1927C)	0.0018 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47993-230-01	15 g in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2014	12/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/08/2014	12/01/2017

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(47993-230)

Revised: 12/2017

Document Id: 604735da-f513-7db1-e053-2991aa0a8a68

Set id: a9bd2382-4338-4e12-a84f-eb0a2774d363

Version: 2

Effective Time: 20171214

NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD