FDA.reportPublic FDA data

Skin Cleansing Wipe

Manufacturer
RFX+CARE Manufacturing Co., Ltd.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:52

Label at a glance#

ProductSkin Cleansing Wipe
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Dosage and administration

Apply topically as needed to cleanse intended area Discard affter single use

Storage and handling

Store at room temperature 15-30C (59-86F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic Cleanser

Use

INDICATIONS & USAGE SECTION

For cleaning the skin and area around minor wounds and abrasions

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from flame or fire

OTC - STOP USE SECTION

Do not use:

  • with electrocautery procesures
  • in the eyes. If contact occurs flush eyes with water

Stop use:

  • if irritation and redness develop
  • if condition persists, consult your health care practitioner

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

Apply topically as needed to cleanse intended area

Discard affter single use

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15-30C (59-86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD3
797544isopropyl alcohol 70 % Medicated PadSY3
797544isopropyl alcohol 70 % Topical ClothSY3
797544isopropyl alcohol 70 % Topical SwabSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82283-001-012025-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-022025-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-032025-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-012023-02-22C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-022023-02-22C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-032023-02-22C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-012023-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-022023-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001
82283-001-032023-01-30C16284748780-1f386c64a-1c72-0266-e053-dadaa90a7c1a82283-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82283-001-01Skin Cleansing Wipe1 in 1 POUCHSOLUTION13
82283-001-01Skin Cleansing Wipe4 mL in 1 APPLICATORSOLUTION43
82283-001-02Skin Cleansing Wipe10 in 1 POUCHSOLUTION103
82283-001-02Skin Cleansing Wipe10 mL in 1 APPLICATORSOLUTION103
82283-001-03Skin Cleansing Wipe10 mL in 1 APPLICATORSOLUTION103
82283-001-03Skin Cleansing Wipe60 in 1 POUCHSOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82283-001SKIN CLEANSING WIPE (ISOPROPYL ALCOHOL) SOLUTION [RFX+CARE MANUFACTURING CO., LTD.]3Legacy NDC, 6 package rows20231130_37819e01-2a83-4e69-8d68-10df8472a5cb.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82283-00182283-001-01, 82283-001-02, 82283-001-03

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
ISOPROPYL ALCOHOLND2M416302ACTIB

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
0b512a58-f509-dfbf-e063-6294a90a8cea37819e01-2a83-4e69-8d68-10df8472a5cb2023-11-29WarningsExact identifier
spl id: 0b512a58-f509-dfbf-e063-6294a90a8cea
spl set id: 37819e01-2a83-4e69-8d68-10df8472a5cb

Reported adverse events (FAERS/openFDA)#

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