DRUG LISTING: RENEW BODY CLEANSER

RENEW BODY CLEANSER by

Drug Labeling and Warnings

RENEW BODY CLEANSER by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RENEW BODY CLEANSER- otc skin protectant drug products lotion 
DermaRite Industries, LLC

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DRUG LISTING: RENEW BODY CLEANSER

Active Ingredient:

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

  • A gentle alternative to soap and water.
  • Cleans, restores, nourishes, and protects even most delicate skin.
  • Ideal for frequent cleansing and incontinence care.

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; symptoms clear up and occur again within a few days.
  • Do not use on deep puncture wounds, animal bites, or serious burns.

Warnings:

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

Directions:

  • For skin care: Apply quarter-sized amount to warm, damp cloth. Wash skin, turning the cloth as the skin is cleansed to remove residue.
  • For incontinence care: Remove excess fecal matter. Follow skin care directions above

Other Information:

Store at room temperature (59°-86°F)

Inactive Ingredients:

Butylparaben, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Ehtylparaben, Fragrance, Glyceryl Stearate, Isobutylparaben, Methyl paraben, PEG-100 Stearate, PEG-20 Glyceryl Stearate, Phenoxyethanol, Propylparaben, Water

Renew Lotion Body Cleanser Package Label Principal Display Panel

image description

RENEW BODY CLEANSER 
otc skin protectant drug products lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61924-430
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61924-430-08228 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/02/201204/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01603/02/201212/31/2024
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-430)

Revised: 12/2024
Document Id: 28880b59-b007-e343-e063-6394a90a1844
Set id: aa6dff13-b952-49ce-bd55-c6f58b303922
Version: 8
Effective Time: 20241205