Raphe Pharmaceutique Pro Vitamin B5 Biotin
FDA Label NDC 82627-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amwiner & Raphe Holdings Llc for the product Raphe Pharmaceutique Pro Vitamin B5 Biotin (NDC 82627-002). 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, purpose, uses, warnings, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Pyrithione Zinc

Purpose

Seborrheic dermatitis

Uses

•Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.
• Helps eliminate recurrence of seborrheic dermatitis

Warnings

For external use only
Ask a doctor before use if condition covers a large area.
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

Apply to affected area one ml two times daily or as directed by the physician

Inactive Ingredients

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin, Saw Palmetto, Finasteride.

Other Information

• Store at 59° to 77°F (15° to 25°C)

* Please review the disclaimer below.