SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL- shierjie disinfecting soft wipes antibacterial cloth 
Shenzhen Shierjie Biological Engineering 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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43116-004
SHIERJIE DISINFECTING SOFT WIPES Antibacterial


Active Ingredient

Benzalkonium Chloride 0.09%
Dodecyl Dimethyl Ammonium Chloride 0.04 %

Purpose

Antimicrobial

Decreases bacteria on skin

Warnings

For external use only.Keep away from heat or flame.

If you are allergic to any of the ingredients.If children less than 2 months of age.

When using this produc, do not get into eyes.If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if iri tation or rash develops and continues for more than 72 hours.

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and over
Apply to hands
Allow to dry without wiping
Children under 2 years
Ask a doctor before use


Other information

/

Inactive ingredients

Aloe Barbadensis Extract , Glycerin , Aqua , Non-woven

Package Label - Principal Display Panel

43116-004-02 43116-004-02

SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL 
shierjie disinfecting soft wipes antibacterial cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.09 g  in 100 
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.04 g  in 100 
Inactive Ingredients
Ingredient NameStrength
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43116-004-0210 in 1 BAG; Type 0: Not a Combination Product12/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/21/2020
Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Shierjie Biological Engineering Co., LTD547610261manufacture(43116-004)

Revised: 12/2020
Document Id: b7051d33-197c-50e0-e053-2995a90a2c7c
Set id: b70522cf-35d8-2d89-e053-2995a90a1a86
Version: 1
Effective Time: 20201221
 
Shenzhen Shierjie Biological Engineering Co., LTD