RENEW DIMETHICONE SKIN PROTECTANT- skin protectant cream 
Dermarite Industries LLC

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.

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DRUG LISTING: Renew Dimethicone Skin Protectant

Active Ingredient:

Dimethicone 5%

Purpose:

Skin Protectant

Uses:

Warnings:

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 tube labelRenew Dimethicone Skin Protectant 4ox box label

RENEW DIMETHICONE SKIN PROTECTANT 
skin protectant cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CANOLA OIL (UNII: 331KBJ17RK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-410-055 g in 1 PACKET; Type 0: Not a Combination Product03/15/2012
2NDC:61924-410-04113 g in 1 TUBE; Type 0: Not a Combination Product03/15/2012
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/FEIBusiness Operations
Dermarite Industries LLC883925562manufacture(61924-410)

Revised: 1/2020
Document Id: 9c58cced-782d-baef-e053-2995a90a383c
Set id: ae82d2b7-eb86-4bbe-825c-f7d7cd7610ad
Version: 5
Effective Time: 20200117
 
Dermarite Industries LLC