ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
Zhejiang Yiwu Anrou Sanitation Article 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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Anrou-PGM, Antibacterial wipes, Benzalkonium Chloride

ACTIVE INGREDIENT

Benzalkonium Chloride, 0.11875%

Cereals Extraction Extract, 0.05%

2-Phenoxyethanol, 0.02025%

2-Methy-4-isothiazolin-3-one, 0.00625%

Iodopropynyl Butylcarbamate, 0.00225%

Purpose

Antibacterial

WARNINGS

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

Do not use

On children less than 2 years of age, or on open skin wounds.

STOP USING AND ASK DOCTOR

If irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Use

Sanitizing Wipe helps to reduce bacteria & virus that can potentially cause disease.

For use when soap & water are not available.

DIRECTIONS

Store in a cool and dry place.

Romove cover.

Pull up wipe corner from center of roll.

Thread through hole in the cover.

Replace cover.

Open center cap on cover to remove wipe.

When not using, close center cap securely to prevent moisture loss.

Reseal and let hands dry.

No need to rinse.

CAUTION

WARNING FLAMMABLE

Keep away from heat, spark, electrical, fire or flame.

Store in a cool and dry place.

INACTIVE INGREDIENT

1,2-Propanediol

Water

Package label. Principal display panel

Pa80

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78356-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.2625 mg
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY2.1 mg
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.84 mg
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) (IODOPROPYNYL BUTYLCARBAMATE - UNII:603P14DHEB) IODOPROPYNYL BUTYLCARBAMATE0.0945 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78356-211-2180 in 1 PAIL; Type 0: Not a Combination Product08/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2020
Labeler - Zhejiang Yiwu Anrou Sanitation Article Co., Ltd (547950139)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Yiwu Anrou Sanitation Article Co., Ltd547950139manufacture(78356-211) , label(78356-211)

Revised: 8/2020
Document Id: ac39716a-ea33-2085-e053-2995a90ad5e8
Set id: ac39716a-ea32-2085-e053-2995a90ad5e8
Version: 1
Effective Time: 20200806
 
Zhejiang Yiwu Anrou Sanitation Article Co., Ltd