PERSONAL CLEANSING CLOTHS WITH DIMETHICONE- dimethicone swab

Personal Cleansing Cloths with Dimethicone by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient

Dimethicone  3.2%

Purpose

Skin Protectant

Uses:

Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness. Temporarily protects and helps relieve chapped or cracked skin.

Warnings:

For external use only.

• Avoid 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 Poison Control Center right away.

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

Heating 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 4 days. Discard wipes that have been:

Exposed to warming temperatures exceeding 52C (125F); or

Stored longer than 4 days 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, Glyceryl Stearate, PEG-100 Stearate , PPG-15 Stearyl Ether, Phenoxyethanol , Caprylyl Glycol , Aloe Barbadensis Leaf Extract, Cetearyl Alcohol, Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

PERSONAL CLEANSING CLOTHS WITH DIMETHICONE 
dimethicone swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-122
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-122-21	42 in 1 CARTON	07/08/2016
1		223 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/05/2016

Labeler - Cardinal Health, Inc. (097537435)