Antibacterial antiseptic wet wipes

Manufacturer
PRISTINE MK LLC | FRESH CO COSMETICS SH.P.K
Effective date
2020-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:02:15

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

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

OTC - PURPOSE SECTION

Antiseptic, Wet Wipes

Use

INDICATIONS & USAGE SECTION

decreases 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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and continues for more than 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 1-800-222-1222

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

deoinised water, Cetearyl isononanoate, Ceteareth-20, Cetearyl alcohol, glyceryl stearate, glycerine,cetearth-12, cetyl-palmitate, phenoxyethanol, sodium benzoate,fragrance, citric acid, disodium EDTA

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 WIPES 120 wipes120 wipes NDC: 81214-600-01

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81214-60081214-600-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
3360a13c-8fb5-a535-e063-6294a90a8348b5b6de8e-9f00-6a3a-e053-2a95a90a93a02025-04-22WarningsExact identifier
spl set id: b5b6de8e-9f00-6a3a-e053-2a95a90a93a0

Reported adverse events (FAERS/openFDA)#

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