PSORACARE - salicylic acid  cream 
Healingsmith Institute Inc.

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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Salicylic Acid 2%

Psoriasis, Seborrheic Dermatitis

controls, fights, and helps prevent skin itching, irritation, redness, flaking and scaling associated with:

For external use only.

Do not use if you are allergic to sesame oil.

Ask a doctor before use if condition covers a large area of the body.

When using this product

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


store in a cool and dry place

Beeswax, Carbomer, Cetyl Alcohol, Coccinia Indica fruit extract, EDTA, Fragrance, Glyceryl Stearate, Holarrhena Antidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylparaben, Stearic Acid, Triethanolamine, Polysorbate 60, White soft paraffin

Psoracare Label

PSORACARE 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76066-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.1 g  in 56.7 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
EDETIC ACID (UNII: 9G34HU7RV0)  
HOLARRHENA PUBESCENS BARK (UNII: 5R6HPB294Y)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SESAME OIL (UNII: QX10HYY4QV)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76066-002-0256.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/02/2012
Labeler - Healingsmith Institute Inc. (962842642)
Registrant - Healingsmith Institute Inc. (962842642)
Establishment
NameAddressID/FEIBusiness Operations
Nikita Containers Private Limited862345246manufacture

Revised: 11/2011
Document Id: c2fa9e06-b36b-4b7a-90d1-31628423a1b6
Set id: c766afe3-3c55-433f-b2cb-b681da734294
Version: 2
Effective Time: 20111128
 
Healingsmith Institute Inc.