Otc - Active Ingredient
Drug Facts
Active Ingredient 2.5% Coal Tar Solution USP (0.5% Coal Tar)
Dermatology Psoriasis Cream
FDA Label NDC 87921-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by G.m.j Natural Products, Inc. for the product Dermatology Psoriasis Cream (NDC 87921-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, other safety information, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose.............. Psoriasis
Indications & Usage
Uses ■ helps prevent the recurrence and relief of symptoms associated with
psoriasis including itching, scaling, flaking, redness, and irritation of the skin
Warnings
Warnings For external use only
Do not use unless directed by a doctor ■ for prolonged periods ■ if condition
covers a large area of the body ■ in or around the rectum or in the genital area
or groin ■ with other forms of psoriasis therapy such as ultraviolet radiation or
prescription drugs
When using this product ■ use caution in exposing skin to sunlight after
applying product. It may increase your tendency to sunburn for up to 24 hours
after application ■ avoid contact with eyes. If contact occurs, rinse thoroughly
with water ■ talk with your physician before you use any other medicines or
cleansers on your skin
Stop use and ask a doctor if symptoms do not improve or if they worsen
after regular use of this product
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a
Poison Control Center (1-800-222-1222) right away
Other Safety Information
WARNING: This product can expose you to chemicals including Coal Tar,
which is known to the state of California to cause cancer. For more
information go to www.P65Warnings.ca.gov
Other Information store in a dry area at 15°-30°C (59°-86°F)
Dosage & Administration
Directions ■ Apply to affected area 1 to 4 times daily or as directed by a
doctor ■ children under 2 years: ask a doctor
Inactive Ingredient
Inactive Ingredients:Alkyl (C12-15) Benzoate, Aloe Barbadensis (Aloe
Vera) Leaf Juice, Arctium Lappa (Burdock) Root Extract, Caprylyl Glycol,
Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chamomilla Recutita
(Chamomile) Flower Extract, Dimethicone, Emulsifying Wax, Ethylhexylglycerin,
Glycerin, Glyceryl Stearate, Hexylene Glycol, Hydrocortisone, Hydrogenated
Polydecene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea
Tree) Leaf, PEG-100, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium
Polyacrylate, Trideceth-6, Xanthan Gum
G.M.J. Natural Products Labeling
----------------------------------------------
G.M.J.
Natural Products
DERMATOLOGY PSORIASIS CREAM
Is formulated specifically to address
the many symptoms of psoriasis,
utilizing specially selected ingredients
for maximum benefit.
4 oz (113 g)
Distributed by: GMJ Natural Products
431 S Acacia Ave.
Fullerton, CA 92831
(714) 254-0682
[email protected]
www.gmjnaturals.com
Box
Psoriasis Box (Psoriasis Box)
Bottle
res
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