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Renew Dimethicone Skin Protectant

Medically reviewed on October 17, 2017

Dosage form: cream
Ingredients: DIMETHICONE 0.05g in 100g
Labeler: Dermarite Industries LLC
NDC Code: 61924-410

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 LISTING: Renew Dimethicone Skin Protectant

Active Ingredient:

Dimethicone 5%

Purpose:

Skin Protectant

Uses:
  • Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool.
  • Temporarily protects and helps relieve chapped or cracked skin.

Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if condition worsens or does not improve within 7 days.
  • Do not use on deep or punctured wounds.

Warnings:

Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions:

Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other Information:

Store at room temperature (59 o- 86 oF)

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.

Questions?

Call 1-800-37-6296

Renew Skin Protectant Package Label Principal Display Panel

RENEW DIMETHICONE SKIN PROTECTANT 
skin protectant cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-410
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ASCORBYL PALMITATE 
BUTYLPARABEN 
CANOLA OIL 
CARBOMER 940 
CETOSTEARYL ALCOHOL 
CHOLECALCIFEROL 
ETHYLPARABEN 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOBUTYLPARABEN 
METHYLPARABEN 
NIACINAMIDE 
OLIVE OIL 
PEG-100 STEARATE 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
PYRIDOXINE HYDROCHLORIDE 
VITAMIN A PALMITATE 
STEARIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
EDETATE DISODIUM 
WATER 
CORN OIL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61924-410-055 g in 1 PACKET
2NDC:61924-410-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/15/2012
Labeler - Dermarite Industries LLC (883925562)
Registrant - Dermarite Industries LLC (883925562)
Establishment
NameAddressID/FEIOperations
Dermarite Industries LLC883925562manufacture(61924-410)

 
Dermarite Industries LLC

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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