dimethicone

Dosage form: cloth
Ingredients: dimethicone 756mg
Labeler: Sage Products Inc.
NDC Code: 53462-915

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.

Drug Facts

Dimethicone 3%

Skin protectant

If swallowed, get medical help or contact a Poison Control Center right away.

  • helps seal out wetness
  • helps treat and prevent perineal dermatitis
  • protects from minor skin irritation associated with perineal dermatitis

Warnings

For external perineal use only.  Avoid contact with the eyes.

Stop use and consult a doctor if condition worsens or does not improve within 7 days


Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • remove wet and soiled garment
  • cleanse soiled area using a fresh barrier cloth
  • use as often as necessary, especially if prolonged exposure to wetness is anticipated
  • for individual use only
  • discard immediately if barrier cloths are dry

water, glycerin, PPG-15 stearyl ether, glyceryl stearate, PEG-100 stearate, stearic acid, aloe barbadensis gel, stearyl alcohol, chlorhexidine gluconate, hydroxyethyl cellulose, methylparaben, propylparaben

barrier cloths:  cellulose fiber/polyester (PET) fiber, 5.5" x 8.5" (small cloths), 8.5" x 8.5" (large cloths)




DIMETHICONE 
dimethicone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-915
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (dimethicone) dimethicone756 mg
Inactive Ingredients
Ingredient NameStrength
water 
glycerin 
PPG-15 STEARYL ETHER 
glyceryl monostearate 
PEG-100 stearate 
stearic acid 
aloe vera leaf 
stearyl alcohol 
chlorhexidine gluconate 
hydroxyethyl cellulose (4000 MPA.S at 1%) 
methylparaben 
propylparaben 
Packaging
#Item CodePackage Description
1NDC:53462-915-503 CLOTH (APPLICATOR) in 1 PACKAGE
2NDC:53462-915-513 CLOTH (APPLICATOR) in 1 PACKAGE
3NDC:53462-915-6024 CLOTH (APPLICATOR) in 1 PACKAGE
4NDC:53462-915-6224 CLOTH (APPLICATOR) in 1 PACKAGE
5NDC:53462-915-808 CLOTH (APPLICATOR) in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/1990
Labeler - Sage Products Inc. (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products Inc.054326178manufacture

Revised: 03/2012
 
Sage Products Inc.

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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