WHITE HAND SANITIZER: Package Insert and Label Information

WHITE HAND SANITIZER- alcohol, .alpha.-tocopherol acetate, dl- and titanium dioxide 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————–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 15ml
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WHITE HAND SANITIZER
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-207
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 0.6 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 19.3 g in 100 g
GLYCERIN 2 g in 100 g
CARBOMER HOMOPOLYMER TYPE C 12 g in 100 g
TRIETHANOLAMINE BENZOATE 3 g in 100 g
ALOE ANDONGENSIS LEAF 1 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47993-207-01 30 g in 1 TUBE None
2 NDC:47993-207-02 30 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/08/2014
Labeler — NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant — NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
Name Address ID/FEI Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD 544493972 manufacture (47993-207)

Revised: 12/2017 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD

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