BENZALKONIUM CHLORIDE- antibacterial hand wipes cloth 
PreCare Corp.

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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Antibacterial Hand Wipes

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Warnings

For external use only.

Do not use

  • in children less than 2 months old.
  • on open skin wounds.

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Aloe Barbadensis Leaf Extract, Citric Acid, Decyl Glucoside, Disodium EDTA, Fragrance, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Benzoate

Questions?

call 718-975-2586

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BioPure Wipes

BENZALKONIUM CHLORIDE 
antibacterial hand wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53118-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53118-140-041400 in 1 CONTAINER; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/14/2022
Labeler - PreCare Corp. (858442403)

Revised: 11/2022
Document Id: eea2e2f3-b372-28fd-e053-2a95a90a4103
Set id: d804dbef-0db1-9271-e053-2995a90abe51
Version: 4
Effective Time: 20221129
 
PreCare Corp.