FDA.reportPublic FDA data

PAPILION HYGIENIC ALCOHOL WIPES ANTIBACTERIAL

Manufacturer
AR KAGIT SAN. ve TIC. LTD. STI.
Effective date
2021-03-08
Label type
HUMAN OTC DRUG LABEL
Version
80321
Source
full-release
Hydrated at
2026-05-31 23:44:26

Label at a glance#

ProductPAPILION HYGIENIC ALCOHOL WIPES ANTIBACTERIAL
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Alcohol wipes to help reduce bacteria that potentially can cause disease.

Dosage and administration

Open package, remove one wet wipe to clean your hands and body. Reseal, keep closed to prevent evaporation. Allow to dry without wiping. Discard propearly after use. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store at room temperature Do not flush down toilet.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Papilion HYGIENIC ALCOHOL WIPES

ANTIBACTERIAL

EXTA PROTECTION AND CLEANING

REDUCE 99% OF GERMS & BACTERIA

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

2. ALOE BARBADENSIS EXTRCT (0.1 % v/v).
3. GLYCERIN (0.5 % v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic/ Antiviral

Purpose

OTC - PURPOSE SECTION

Papilion HYGIENIC ALCOHOL WIPES

ANTIBACTERIAL

Uses

INDICATIONS & USAGE SECTION

Alcohol wipes to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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 use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Open package, remove one wet wipe to clean your hands and body. Reseal, keep closed to prevent evaporation.

Allow to dry without wiping. Discard propearly after use.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Do not flush down toilet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe barbadensis Extract.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​ NDC: 79262-130-01​ NDC: 79262-130-0164 PCS LABEL64 PCS LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN80321
1307051ethanol 0.75 ML/ML Medicated PadSCD80321
1307051ethanol 75 % Hand Sanitizer WipesSY80321
1307051ethyl alcohol 75 % Topical ClothSY80321

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79262-130-022022-07-29C16284748780-1e4f33bdf-b33a-d8a0-e053-dadaa90a6e4eb9b86025-06ae-6884-e053-2a95a90a4c0e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79262-130-01PAPILION HYGIENIC ALCOHOL WIPES ANTIBACTERIAL2.916 mL in 1 PATCHCLOTH2.91680321
79262-130-02PAPILION HYGIENIC ALCOHOL WIPES ANTIBACTERIAL64 in 1 PACKAGECLOTH6480321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79262-130PAPILION HYGIENIC ALCOHOL WIPES ANTIBACTERIAL (ALCOHOL) CLOTH [AR KAGIT SAN. VE TIC. LTD. STI.]80321Legacy NDC, 2 package rows20211024_b9b86025-06ae-6884-e053-2a95a90a4c0e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79262-13079262-130-01, 79262-130-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
ALOE ARBORESCENS LEAF09TD8L5SQVIACT

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
bd0970e3-4c0b-2a51-e053-2a95a90a0410b9b86025-06ae-6884-e053-2a95a90a4c0e2021-03-08WarningsExact identifier
spl id: bd0970e3-4c0b-2a51-e053-2a95a90a0410
spl set id: b9b86025-06ae-6884-e053-2a95a90a4c0e

Reported adverse events (FAERS/openFDA)#

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