FDA.reportPublic FDA data

Wipe Outz Cleansing Tattoo Wipes

Manufacturer
Purocol LLC
Effective date
2022-03-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:35

Label at a glance#

ProductWipe Outz Cleansing Tattoo Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

For adults and children 2 years and older, apply wipe thoroughly to cleanse area

Dosage and administration

STORAGE:  Store at room temperature DISPENSING:  Flip open the dispensing cap. Peel back the security label. Remove wipes. To reseal, slightly press on dispensing cap. USE:  Apply wipe thoroughly to fresh tattoo. Allow to dry without wiping. DIPOSAL:  Dispose of used wipes in trash bin after use. DO NOT FLUSH!

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For adults and children 2 years and older, apply wipe thoroughly to cleanse area

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears and lasts 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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • STORAGE: Store at room temperature
  • DISPENSING: Flip open the dispensing cap. Peel back the security label. Remove wipes. To reseal, slightly press on dispensing cap.
  • USE: Apply wipe thoroughly to fresh tattoo. Allow to dry without wiping.
  • DIPOSAL: Dispose of used wipes in trash bin after use. DO NOT FLUSH!

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Purified water, Propylene Glycol, Didecyldimonium Chloride, Polyaminopropyl Biguanide, Aloe Barbadensis Lea Water, Phenoxyethanol, Edetate Disodium Anhydrous, Dimethicone, Peg-40 Hydrogenated Castor Oil.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75266-003-012024-01-30C16284748780-11030e365-27a0-111a-e063-dadaa90a10e2Wipe Outz Cleansing Tattoo Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75266-003-01Wipe Outz Cleansing Tattoo Wipes40 in 1 CARTONCLOTH403
75266-003-01Wipe Outz Cleansing Tattoo Wipes1 in 1 PACKETCLOTH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75266-003WIPE OUTZ CLEANSING TATTOO WIPES (BENZALKONIUM CHLORIDE) CLOTH [PUROCOL LLC]3Legacy NDC, 2 package rows20220302_c10c66e5-8214-0561-e053-2a95a90a3003.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75266-00375266-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIMETHICONE92RU3N3Y1OIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d92d9269-7546-2f0e-e053-2a95a90ab0d6c10c66e5-8214-0561-e053-2a95a90a30032022-03-01WarningsExact identifier
spl id: d92d9269-7546-2f0e-e053-2a95a90ab0d6
spl set id: c10c66e5-8214-0561-e053-2a95a90a3003

Reported adverse events (FAERS/openFDA)#

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