Alcohol Free Hand Sanitizer: Package Insert and Label Information

ALCOHOL FREE HAND SANITIZER- benzalkonium chloride 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

Benzalkonium Chloride……….0.3%

Uses:
Keep skin Clean. Recommended for repeated use.

Warnings:

For external use only.Keep out of eyes.In case of eye contact immediately flush with water,call a doctor.If swallowed call a doctor.

Directions:

Squeeze small amount in your palm and briskly rub hands together 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,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,Glycerine,Fragrance

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ALCOHOL FREE HAND SANITIZER
alcohol free hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-231
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 94.7 g in 100 g
ALPHA CELLULOSE 1.4 g in 100 g
TROLAMINE 1 g in 100 g
HYDROGENATED CASTOR OIL 0.4 g in 100 g
GLYCERIN 2 g in 100 g
AROMADENDRIN 0.2 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47993-231-01 10 g in 1 BOTTLE None
2 NDC:47993-231-02 15 g in 1 BOTTLE None
3 NDC:47993-231-03 30 g in 1 BOTTLE None
4 NDC:47993-231-04 50 g in 1 BOTTLE None
5 NDC:47993-231-05 60 g in 1 BOTTLE None
6 NDC:47993-231-06 100 g in 1 BOTTLE None
7 NDC:47993-231-07 237 g in 1 BOTTLE None
8 NDC:47993-231-08 500 g in 1 BOTTLE None
9 NDC:47993-231-09 800 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/20/2015
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 (47993-231)

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

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