PSORIAS SKIN- coal tar ointment 
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

Coal Tar 5% ( from Coal         For the relief of Psoriasis
Tar Solution USP, 25% )         and/or Seborrheic Dermatitis

Uses:


For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including: itching • scaling • flaking • redness • irritation of the skin. Helps prevent recurrence

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

Warnings
For external use only

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. • Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. • If condition worsens or does not improve after regular use of this product as directed, consult a doctor. • Do not use this product in or around the rectum or in the genital area or groin, except on the advice of a doctor. • Do not use for prolonged periods without consulting a doctor. • If condition covers a large area of the body, consult your doctor before using this product.• Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. • If this product causes increased irritation, discontinue use and seek medical advice. Warning: This product contains chemicals known to the state of California to cause cancer

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 after removing loose scales.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Anthemis Nobilis (Chamomile) Flower Oil, Beeswax, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Melaleuca Alteimage descriptionrnifolia (Tea Tree) Leaf Oil, Methylparaben, Mineral Oil, Octyldodecanol,Oenothera Biennis (Evening  Primrose) Oil, Petrolatum, Polysorbate 80, Propylparaben, Triethoxycaprylylsilane, Urea, Zinc Oxide

image description

PSORIAS SKIN 
coal tar ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-7130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Coal Tar (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) Coal Tar1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TEA TREE OIL (UNII: VIF565UC2G)  
Methylparaben (UNII: A2I8C7HI9T)  
Mineral Oil (UNII: T5L8T28FGP)  
Octyldodecanol (UNII: 461N1O614Y)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
Petrolatum (UNII: 4T6H12BN9U)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylparaben (UNII: Z8IX2SC1OH)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Urea (UNII: 8W8T17847W)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-7130-41 in 1 CARTON06/21/201210/31/2017
1101 mL in 1 BOTTLE; 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(64048-7130) , label(64048-7130)

Revised: 10/2017
 
Product Quest Mfg.