Antibacterial Wet Wipes

Manufacturer
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:10:17

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Benzalkonium chloride 0.1%...........Antiseptic

Uses

Use

decreases bacteria on skin

Warnings

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients.

Stop use and ask a doctor

if irritation or rash develops and continues for more than 72 hours

Directions And Dosage

Directions

For adults and children of 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years ask a doctor before use.

Other Label Information

INACTIVE INGREDIENT SECTION

water, propylene glycol, cocamidopropyl betaine, poly(hexamethyleneguanidine),PEG-7 glyceryl cocoate , hydrochloride, glycine, tetrasodium EDTA, tocopheryl acetate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil.

Label Images#

wet wipes
wet wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN2
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD2
1038856benzalkonium chloride 0.1 % Medicated WipesSY2
1038856benzalkonium chloride 0.1 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76772-008-402022-01-28C16284748780-1d6a99b39-56fd-a426-e053-dadaa90af4c2ANTIBACTERIAL WET WIPES 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-008-40Antibacterial Wet Wipes40 in 1 PACKAGESWAB402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-008ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) SWAB [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20200508_dcafea3f-0731-41ed-94dd-a1ca20f67a2b.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-00876772-008-40

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1%...........Antiseptic

Use

INDICATIONS & USAGE SECTION

decreases bacteria on skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients.

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash develops and continues for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children of 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years ask a doctor before use.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

water, propylene glycol, cocamidopropyl betaine, poly(hexamethyleneguanidine),PEG-7 glyceryl cocoate , hydrochloride, glycine, tetrasodium EDTA, tocopheryl acetate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil.

Source Document#

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