FDA.reportPublic FDA data

Personal Cleansing with Dimethicone

Manufacturer
Cardinal Health 200, Inc.
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:23:57

Label at a glance#

ProductPersonal Cleansing with Dimethicone
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin helps prevent perineal dermatitis  protects minor skin irritation associated with perineal dermatitis

Dosage and administration

Pull back label and remove wipes Thoroughly cleanse soiled area, using one wipe at a time Use as often as necessary Dispose of cloths in a waste receptacle Do not flush  Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed: In a single warming session at temperatures not exceeding 52°C (125°F) and  for a maximum of 200 hours. Discard wipes t...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent perineal dermatitis 
  • protects minor skin irritation associated with perineal dermatitis

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid direct contact with the eyes

Stop use and contact a physician

OTC - STOP USE SECTION

  • if condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • Discontinue if irritation or redness develops
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Do not use

OTC - DO NOT USE SECTION

  • On deep or puncture wounds
  • Animal bites
  • Serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pull back label and remove wipes
  • Thoroughly cleanse soiled area, using one wipe at a time
  • Use as often as necessary
  • Dispose of cloths in a waste receptacle
  • Do not flush 
  • Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:
  • In a single warming session at temperatures not exceeding 52°C (125°F) and 
  • for a maximum of 200 hours. Discard wipes that have been:
  • Exposed to warming temperatures exceeding 52°C (125°F); or 
  • Stored longer than 200 hours within the warmer; or
  • Been warmed, allowed to cool, and then re-warmed

Warming Instructions:

Other Information

SPL UNCLASSIFIED SECTION

When not in a warmer, store between 15-30°C (59-86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
63517-12563517-125-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PPG-15 STEARYL ETHER1II18XLS1LIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
18fd803d-673f-e2cb-e063-6294a90a5270a2f5545e-d639-471a-9732-06bcac8add602024-05-21WarningsExact identifier
spl set id: a2f5545e-d639-471a-9732-06bcac8add60

Reported adverse events (FAERS/openFDA)#

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