PSORACARE- salicylic acid cream

PsoraCare by

Drug Labeling and Warnings

PsoraCare by is a Otc medication manufactured, distributed, or labeled by Healingsmith Institute Inc., Nikita Containers Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2%

PURPOSE

Psoriasis, Seborrheic Dermatitis

INDICATIONS & USAGE

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

• psoriasis
• seborrheic dermatitis
  

WARNINGS

For external use only.

DO NOT USE

Do not use if you are allergic to sesame oil.

ASK DOCTOR

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

WHEN USING

When using this product

• avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
• if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results
  

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• apply liberally to affected areas one to four times daily or as directed by a doctor
• children under 2 years of age: consult a doctor
  

STORAGE AND HANDLING

store in a cool and dry place

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSORACARE 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76066-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.1 g  in 56.7 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76066-002-02	56.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/02/2012

Labeler - Healingsmith Institute Inc. (962842642)

Registrant - Healingsmith Institute Inc. (962842642)

Establishment
Name	Address	ID/FEI	Business Operations
Nikita Containers Private Limited		862345246	manufacture