Cotton Soft

Manufacturer
SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI | MASTER CUSTOMS BROKER
Effective date
2021-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:28

Label at a glance#

ProductCotton Soft
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Lift the tab on the top of the lid to open Open moisture seal film package before use. Pull out first wipe through the dispensing center of the canister. Next sheets pops up automatically. Close the lid to retain moisture. Wipe down with this product. Let air dry.

Storage and handling

Store at room temperature between 15-30C (59-86F) Lot No., manufacture date and expiration date can be found on package.

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 World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).
  3. Hydrogen peroxide (0.125% 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

Ethyl Alcohol 75%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For Hand sanitizing to decrease bacteria and germs on skin

Apply topically to skin to help prevent cross contamination

Dries in seconds

Warnings

WARNINGS SECTION

For external use only. Harmful if shallowed

Highly Flammable.

Keep away from heat or flame.

Avoid contact with open or exposed skin wounds

Do not use

OTC - DO NOT USE SECTION

  • Do not use as baby wipes
  • Do not flush down the toilets
  • Do not use in or contact the eyes

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation and sensitivity develops or increases.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation and sensitivity develops or increases.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Lift the tab on the top of the lid to open
  • Open moisture seal film package before use.
  • Pull out first wipe through the dispensing center of the canister. Next sheets pops up automatically.
  • Close the lid to retain moisture.
  • Wipe down with this product. Let air dry.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature between 15-30C (59-86F)
  • Lot No., manufacture date and expiration date can be found on package.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water

Hand Sanitizing wipes-Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizing wipes 50 pcs NDC: 81406-001

Hand Sanitizing WipesHand Sanitizing Wipes

Hand Sanitizing Wipes- 50 pcs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizing Wipes- 50 pcs

NDC: 81406-001-50

Wet Wipes Cotton Soft 50 PcsWet Wipes Cotton Soft 50 Pcs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN3
1307051ethanol 0.75 ML/ML Medicated PadSCD3
1307051ethanol 75 % Hand Sanitizer WipesSY3
1307051ethyl alcohol 75 % Topical ClothSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81406-001-502023-01-30C16284748780-1f386c649-c851-0266-e053-dadaa90a7c1aHAND SANITIZING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81406-001-50Cotton Soft220 g in 1 POUCHCLOTH2203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81406-001COTTON SOFT (HAND SANITIZING WIPES) CLOTH [SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI]3Legacy NDC, 1 package rows20211027_b83f5b55-d8d6-ca85-e053-2995a90a0a70.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81406-00181406-001-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
cf37069b-af7a-1714-e053-2a95a90a8127b83f5b55-d8d6-ca85-e053-2995a90a0a702021-10-25WarningsExact identifier
spl id: cf37069b-af7a-1714-e053-2a95a90a8127
spl set id: b83f5b55-d8d6-ca85-e053-2995a90a0a70

Reported adverse events (FAERS/openFDA)#

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