PERSONAL CLEANSING WITH DIMETHICONE- dimethicone cloth

Personal Cleansing with Dimethicone by

Drug Labeling and Warnings

Personal Cleansing with Dimethicone by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 200, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 

Warming Instructions:

• 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

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:

INGREDIENTS AND APPEARANCE

PERSONAL CLEANSING WITH DIMETHICONE 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-126
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-126-21	42 in 1 PACKET	05/15/2019
1		1 in 1 POUCH
1		28.59 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/15/2019

Labeler - Cardinal Health 200, Inc (961027315)