PSORIASIS SCALP MASGATT N9- salicylic acid 3.0 cream 
Product Quest Mfg.

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 Facts

Active Ingredient                     Purpose

Salicylic Acid 3%                      For the relief of Psoriasis and/or Seborrheic Dermatitis and/or Dandruff

Uses:

For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis and/or dandruff including:

itching • scaling • flaking • redness • irritation of the skin. Helps prevent recurrence.

Warnings
For external use only.

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. • If condition worsens or does not improve after regular use of this product as directed, consult a doctor. • If condition covers a large area of the body, consult your doctor before using this product. If this product causes increased irritation, discontinue use and seek medical advice.

Keep out of the reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions:

Use only as directed. Apply to affected areas one to
four times daily or as directed by a doctor. Massage
well into affected areas. Optimally, this product should
be applied to the scalp and left overnight

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, C12-15 Alkyl Benzoate, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin,  Methylparaben, Propylparaben, Propylene Glycol, Prunus Amigdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil,  Sodium Hydroxide, Sorbitan Oleate, Triethanolamine, Water.

image description

PSORIASIS SCALP  MASGATT N9
salicylic acid 3.0 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-7129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SESAME OIL (UNII: QX10HYY4QV)  
Sodium Hydroxide (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-7129-41 in 1 CARTON06/21/201210/31/2017
1101 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/21/201210/31/2017
Labeler - Product Quest Mfg. (927768135)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(64048-7129)

Revised: 10/2017
 
Product Quest Mfg.