Pc-tar
FDA Label NDC 54162-200
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Pc-tar (NDC 54162-200). 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 active ingredient:coal tar 1%, intended uses:, directions:, warnings:, keep out of reach of children, inactive ingredients:, for questions, comments, or informationcall 1-800-736-3437, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Intended Uses:
To provide temporary relief to itchy, dry, and/or flaky scalp conditions
Directions:
Shake well before using
Wet hair and scalp thoroughly
Massage shampoo into hair and scalp and work into a rich lather
Leave shampoo on hair for several minutes
Rinse and repeat
Rinse thoroughly with water
Warnings:
If condition covers a large part of the body, consult a physician before using this product
When using this shampoo protect the treated area from direct sunlight. It may increase your tendency to sunburn for up to 24 hours after using this product.
In rare instances hair discoloration may occur to gray, blonde, bleached, or tinted hair.
Do not use for prolonged periods without consulting a physician.
If improvement does not occur, or condition worsens after regular use or as directed, consult a physician
FOR EXTERNAL USE ONLY
Keep Out Of Reach Of Children
Inactive Ingredients:
Purified water, Cocamide DEA, Polysorbate 20 & 80, Cocamphocarboxy Glyceride, EDTA, Fragrance, Magnesium Aluminum Silicate, PEG-75 Lanolin, Hexeylene Glycol, Sodium Polnapthalene Sulfonate, 0.5% Parachlorometaxylenol (antimicrobial preservative)
For Questions, Comments, Or Informationcall 1-800-736-3437
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