Fresh Antibacterial Antiseptic Wet Wipes

Antibacterial Antiseptic Wet Wipes by

Drug Labeling and Warnings

Antibacterial Antiseptic Wet Wipes by is a Otc medication manufactured, distributed, or labeled by FRESH CO COSMETICS SH.P.K.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL ANTISEPTIC WET WIPES- benzalkonium chloride cloth 
FRESH CO COSMETICS SH.P.K.

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Fresh Antibacterial Antiseptic Wet Wipes

Active Ingredient(s)

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Antibacterial Wet Wipes

Use

Decrease bacteria on skin. For use when soap and water are not available.

Warnings

For external use only.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product do not get into eyes, ears, and mouth. If contact occurs,rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for morethan 72 hours. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Stop use and ask a doctor if irritation ordevelops and continues for morethan 72 hours. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1800-222-1222.

Directions

adults and children 2 years and over

  • apply to hands
  • wet hands thoroughly with product and allow it to dry

children under 2 years

  • ask a doctor before use

Directions for use

  • to dispense peel back front label slowly remove wipes.
  • to reseal pouch firmly run thumb over the label.
  • donot flush

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat

Inactive ingredients

deionised water, ceteary isononanoate,cetearyl alcohol, glyceryl stearate, glycerin, ceteareth-12, cetyl palmitate, phenoxyethanol, sodium benzoate, fragrance, citric acid, disodium EDTA

Package Label - Principal Display Panel

48 wet wipes NDC: 80638-150-48 Wet wipes 48

102 wet wipes NDC: 80638-150-12

wet wipes 102

ANTIBACTERIAL ANTISEPTIC WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80638-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETEARYL ISONONANOATE (UNII: P5O01U99NI) 0.08 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.08 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 0.08 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.08 mL  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.08 mL  in 100 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.08 mL  in 100 mL
CETYL PALMITATE (UNII: 5ZA2S6B08X) 0.3 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.08 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.08 mL  in 100 mL
CETEARETH-12 (UNII: 7V4MR24V5P) 0.3 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80638-150-48290 mL in 1 POUCH; Type 0: Not a Combination Product09/18/2020
2NDC: 80638-150-12590 mL in 1 POUCH; Type 0: Not a Combination Product09/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01609/18/202001/01/2025
Labeler - FRESH CO COSMETICS SH.P.K. (499428868)
Establishment
NameAddressID/FEIBusiness Operations
FRESH CO COSMETICS SH.P.K.499428868manufacture(80638-150)

Revised: 1/2025
Document Id: 2c721757-c826-7afb-e063-6394a90a3f1f
Set id: afeb47b6-5240-26f2-e053-2a95a90a573b
Version: 4
Effective Time: 20250124