DERMASARRA- otc topical analgesic drug products lotion 
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: DERMASARRA

Active Ingredient

Camphor 0.5%

Purpose

External Analgesic

Uses:

Temporary relief of itching associiated with minor skin irritations due to:

Warnings:

Warnings

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor

Other Infomation:

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, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

Questions?

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

DermaSarra Package Label Principal Display Panel

Package.Label Principal Display Panel

DERMASARRA 
otc topical analgesic drug products lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-189
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.005 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
IMIDUREA (UNII: M629807ATL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PEG-4 DILAURATE (UNII: KCR71CW036)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-189-08222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2010
Labeler - DERMARITE INDUSTRIES, LLC (883925562)
Registrant - DERMARITE INDUSTRIES, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DERMARITE INDUSTRIES, LLC883925562manufacture(61924-189)

Revised: 1/2022
Document Id: d58c8d23-4797-535b-e053-2a95a90ab26f
Set id: 1fad8650-8bd6-4711-9121-b9f6ff8bdf6b
Version: 6
Effective Time: 20220114
 
DERMARITE INDUSTRIES, LLC