Antibacterial Antiseptic Wet Wipes

Manufacturer
FRESH CO COSMETICS SH.P.K.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:08

Label at a glance#

ProductAntibacterial Antiseptic Wet Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Antibacterial Wet Wipes

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

102 wet wipes NDC: 80638-150-12

wet wipes 102wet wipes 102

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80638-15080638-150-48, 80638-150-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33609d87-51a4-af4b-e063-6394a90a4551afeb47b6-5240-26f2-e053-2a95a90a573b2025-04-22WarningsExact identifier
spl set id: afeb47b6-5240-26f2-e053-2a95a90a573b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.