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Personal Cleansing Cloths with Dimethicone

Medically reviewed on November 10, 2017

Dosage form: swab
Ingredients: DIMETHICONE 3.32g in 100g
Labeler: Cardinal Health, Inc.
NDC Code: 63517-121

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.

Personal Cleansing Cloths with Dimethicone, 18 count

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:

PERSONAL CLEANSING CLOTHS WITH DIMETHICONE 
dimethicone swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE3.32 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
PPG-15 STEARYL ETHER 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
ALOE VERA LEAF 
CETOSTEARYL ALCOHOL 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:63517-121-2118 PACKAGE in 1 CARTON
195 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/04/2015
Labeler - Cardinal Health, Inc. (097537435)

 
Cardinal Health, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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