ANTIBACTERIAL WET WIPES- antibacterial wet wipes 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.

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Active Ingredients

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

ANTIBACTERIAL WET WIPES 
antibacterial wet wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 95.5 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.1 g  in 100 g
ISOTHIAZOLINONE (UNII: E57JT172V7) 0.1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-400-0210 in 1 BOTTLE09/15/2016
1NDC:47993-400-013 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:47993-400-0430 in 1 BOTTLE09/15/2016
2NDC:47993-400-033 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:47993-400-0610 in 1 PACKAGE09/15/2016
3NDC:47993-400-053 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:47993-400-0830 in 1 PACKAGE09/15/2016
4NDC:47993-400-073 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2016
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-400)

Revised: 12/2017
Document Id: 5fab2012-60d5-b030-e053-2991aa0a639e
Set id: f0c8ab61-d784-46ab-a770-a4417bfe1ddf
Version: 2
Effective Time: 20171206
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD