Flakes Cedar Mint Anti Dandruff Lotion/shampoo
FDA Label NDC 52261-1400

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 Flakes Cedar Mint Anti Dandruff (NDC 52261-1400). 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 - keep out of reach of children, otc - when using, indications & usage, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:                  Purpose:

Pyrithione Zinc 2%..................Anti dandruff

Otc - Purpose

Use:  For the control of the symptoms of dandruff and or seborrheic dermatitis

Warnings

Warnings

for external use only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  

If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Indications & Usage

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Dosage & Administration

Directions: for best results, use at least twice a week or as directed by a doctor.
• Wet hair thoroughly
• Massage a liberal amount into your scalp
• Leave lather on scalp for several minutes
• Rinse and repeat.

Inactive Ingredient

Inactive Ingredients:
WATER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCO MONOETHANOLAMIDE, FRAGRANCE, GLYCERIN, PHENOXYETHANOL, PEPPERMINT OIL, HYDROXYPROPYL GUAR, HYDROXYPROPYL TRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, POLYACRYLATE CROSSPOLYMER-6, METHYL DIISOPROPYL PROPIONAMIDE, TEA TREE OIL, CITRIC ACID

Storage And Handling

Other Information
Store at room temperature between 68-77°F (20-25°C).
Do not expose to excessive heat

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