INCONTINENCE CARE WIPE- dimethicone swab
Cardinal Health 200, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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incontinence care wipe

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 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:

Tear open pouch 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 0C (125 0F) and
for a maximum of 4 days.

Discard wipes that have been:

Exposed to warming temperatures exceeding 52 0C (125 0F); 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 0C (59-86 0F)

Inactive Ingredients:

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

Product Label

Carton

INCONTINENCE CARE WIPE
dimethicone swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-131
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 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
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)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63517-131-21	3 in 1 CARTON	08/21/2015	04/18/2021
1		20 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/21/2015	04/18/2021

Labeler - Cardinal Health 200, Inc. (961027315)

Revised: 11/2022

Document Id: edb77a68-8a36-eebe-e053-2a95a90a2a29

Set id: 5eb15b59-4d5f-48b6-a09f-a62704ceff48

Version: 4

Effective Time: 20221117

Cardinal Health 200, Inc.