FDA.reportPublic FDA data

PAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER

Manufacturer
AR KAGIT SAN. ve TIC. LTD. STI.
Effective date
2021-02-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:38:38

Label at a glance#

ProductPAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

Dosage and administration

Put enough product in your palm to cover hands and rub hands together until dry. Children under 6 years should be supervised when using this product.

Storage and handling

Store below 106 F (41 C). May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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) 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. Glycerol (0.5% v/v).
  3. Aloe Vera Leaf (0.1% v/v).
  4. Carbomer 940 (0.33% v/v).
  5. Triethanolamin (0.2% v/v).
  6. Sterile distilled 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

Purpose

OTC - PURPOSE SECTION

Antiseptic, Papilion Hygienic Antibacterial Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness devolops and lasts.

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

  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 106 F (41 C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 79262-110-02 500 ml500 ml 500 ml text500 ml text

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN4
1305100ethanol 0.75 ML/ML Topical GelSCD4
1305100ethanol 75 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79262-110-022022-07-29C16284748780-1e4f33bdf-a5dc-d8a0-e053-dadaa90a6e4eb098d9b5-9f6d-2ea8-e053-2a95a90a7aef

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79262-110-02PAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79262-110PAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [AR KAGIT SAN. VE TIC. LTD. STI.]4Legacy NDC, 1 package rows20210301_b098d9b5-9f6d-2ea8-e053-2a95a90a7aef.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79262-11079262-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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
bc65ef4b-cd4e-79d4-e053-2995a90a63b4b098d9b5-9f6d-2ea8-e053-2a95a90a7aef2021-02-28WarningsExact identifier
spl id: bc65ef4b-cd4e-79d4-e053-2995a90a63b4
spl set id: b098d9b5-9f6d-2ea8-e053-2a95a90a7aef

Reported adverse events (FAERS/openFDA)#

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