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RENEW SKIN REPAIR

Medically reviewed by Drugs.com. Last updated on Jan 17, 2020.

Dosage form: cream
Ingredients: DIMETHICONE 0.015g in 100g
Labeler: Dermarite Industries LLC
NDC Code: 61924-405

DRUG LISTING: RENEW SKIN REPAIR CREAM

Active Ingredient:

Dimethicone 1.5%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body, and legs.

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 and if symptoms clear up and occur again within a few days.
  • Do not use on deep or punctured wounds, animal bites, or serius burns.

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

Directions:

Apply cream liberally as needed.

Other Information:
  • Store at room temperature (59 o- 86 oF)
  • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Infredients:

Water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil, Stearic Acid, glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Glycerin, Butylparaben, Ethylparaben, Isobutylparaben, methylparaben, Phenoxyethanol, propylparaben, Citrus Aurantium Dulcis (orange) Peel Oil, Anthemis Nobilis Flower Oil, Lavandula Officinalis (lavender) Oil, Fragrance, Cetearyl Alcohol, Carbomer, Ascorbyl Palmitate, Disodium EDTA, Tocopheryl Acetate, Niacinamide, Retinyl Palmitate, Cholecalciferol, Pyridoxine HCL

Questions?

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

Package Label Principal Display Panel

RENEW SKIN REPAIR 
otc skin protectant drug products cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-405
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.015 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:61924-405-27793 g in 1 BAG
2NDC:61924-405-04113 g in 1 TUBE
3NDC:61924-405-32907 g in 1 BOTTLE, PUMP
4NDC:61924-405-055 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/03/2011
Labeler - Dermarite Industries LLC (883925562)
Registrant - Dermarite Industries LLC (883925562)
Establishment
NameAddressID/FEIOperations
Dermarite Industries LLC883925562manufacture(61924-405)

 
Dermarite Industries LLC

Further information

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

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