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Renew Dimethicone Skin Protectant

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:
  • Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

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 or clear up and occur again within a few days.

Warnings:

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

Directions:
  • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information:

Store at room temperature (59°-86°F). You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil, Stearic Acid, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Phenoxyethanol, Isobutylparaben, Glycerin, Aloe Barbadensis Leaf Juice, Citrus medica Limonum (lemon) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cananga Odorata Flower Oil, Cetearyl Acetate, Disodium EDTA, Niacinamide, Retinyl Palmitate, cholecalciferol, Pyridoxine HCL

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

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

Medically reviewed on Sep 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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