PERSONAL CLEANSING WITH DIMETHICONE- dimethicone cloth
Cardinal Health 200, Inc.

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Personal Cleansing Cloth with Dimethicone

Drug Facts

Active Ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

When using this product

Avoid direct contact with the eyes

Stop use and contact a physician

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.

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

On deep or puncture wounds
Animal bites
Serious burns

Directions

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

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

Inactive Ingredients

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

Package Labeling:

Label3

PERSONAL CLEANSING WITH DIMETHICONE
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-125
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	32 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63517-125-21	18 in 1 PACKET	05/15/2019	03/31/2020
1		1 in 1 POUCH
1		10.34 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	05/15/2019	03/31/2020

Labeler - Cardinal Health 200, Inc. (961027315)

Revised: 5/2024

Document Id: 18fd803d-673f-e2cb-e063-6294a90a5270

Set id: a2f5545e-d639-471a-9732-06bcac8add60

Version: 5

Effective Time: 20240521

Cardinal Health 200, Inc.