Antibacterial Wet Wipes: Package Insert and Label Information

ANTIBACTERIAL WET WIPES- benzalkonium chloride swab
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:

Benzalkonium Chloride 0.3%

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

Warnings:

For external use only.Keep out of eyes.Discontinue use if irritation or redness develops.Keep out of reach of children except with adult

supervision.Do not flush down toilet.

Directions:

Open packet,remove and unfold pre-moistened tissue.Wipe hands including nails and cuticles.Allow to dry without wiping.Discard properly

after use

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(aqua),Propylene Glycol,Tocopherol,Kathon

image of antibacterial wet wipes
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ANTIBACTERIAL WET WIPES
antibacterial wet wipes swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47993-400
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 95.5 g in 100 g
PROPYLENE GLYCOL 4 g in 100 g
TOCOPHEROL 0.1 g in 100 g
ISOTHIAZOLINONE 0.1 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47993-400-02 10 POUCH in 1 BOTTLE contains a POUCH (47993-400-01)
1 NDC:47993-400-01 3 g in 1 POUCH This package is contained within the BOTTLE (47993-400-02)
2 NDC:47993-400-04 30 POUCH in 1 BOTTLE contains a POUCH (47993-400-03)
2 NDC:47993-400-03 3 g in 1 POUCH This package is contained within the BOTTLE (47993-400-04)
3 NDC:47993-400-06 10 POUCH in 1 PACKAGE contains a POUCH (47993-400-05)
3 NDC:47993-400-05 3 g in 1 POUCH This package is contained within the PACKAGE (47993-400-06)
4 NDC:47993-400-08 30 POUCH in 1 PACKAGE contains a POUCH (47993-400-07)
4 NDC:47993-400-07 3 g in 1 POUCH This package is contained within the PACKAGE (47993-400-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/15/2016
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 (47993-400)

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

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