Drug Facts
Active Ingredients:
Coal Tar Solution 1.8%..................Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis
Menthol 1.5%..............................Contols scalp itch
Pete And Pedro
FDA Label NDC 52261-0900
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Pete And Pedro (NDC 52261-0900). 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 drug facts, otc - purpose, warnings, otc - do not use, otc - ask doctor, indications & usage, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Product relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis. Provide relief of itching due to dandruff.
Warnings
Warnings: For external use only.
WARNING: This product contains a chemical known to the State of California to cause cancer.
Otc - Do Not Use
Do not use for prolonged periods without consulting a doctor or with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a physician.
Otc - Ask Doctor
Ask a doctor before use if you have a conditiion that covers a large area of the body.
Indications & Usage
When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water. Use caution in exposing skin to sunlight after applying. It may increase you tendency to sunburn for up to 24 hours after application.
Otc - Stop Use
Stop use and ask doctor if condition worsens or does not improve after regular use of the product as directed.
Otc - 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
DIRECTIONS: Shake well and apply shampoo to wet hair. Gently massage it into hair and scalp to work up a lather. Rinse hair thoroughly and repeat for best results. Use at least twice a week or as directed by a doctor.
Storage And Handling
Other Information: Store at room temperature between 68-78
Inactive Ingredient
Inactive Ingredients: Caprylyl Glycol, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Ethanol, FD&C Blue #1, Glycerin, Guar Gum, Hydroxypropyl Methylcellulose, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Sodium Laureth Sulfate, Water, Zinc Stearate
Otc - Questions
Questions: 1 (404) 918-0020 or www.peteandpedro.com
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