Prosoria Medicated Lotion/shampoo
FDA Label NDC 71573-121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvothera, Inc. for the product Prosoria Medicated (NDC 71573-121). 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 other, active ingredient, purpose, uses, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Nuvothera, Inc.
Fort Worth, Texas 76104

Active Ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

for the relief of itching, irritation, redness, flaking, scaling associated with dandruff and seborrheic dermatitis.

Warnings

For external use only

When Using This Product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • if condition worsens or does not improve after regular use of this product as directed, consult a doctor.

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.

Directions

  • for best results use at least twice a week or as directed by a doctor.
  • for maximum control, use every time you shampoo.
  • shake bottle before use.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Other Information

  • store at room temperature 59-77°F (15-25°C).

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, D&C YELLOW 10, FD&C RED 40, Guar Hydroxypropyltrimonium Chloride, Panthenol, Phenoxyethanol, Propylene Glycol, Water, Sodium Laureth Sulfate, Stearyl Alcohol, Tocopheryl Acetate, Xanthan Gum.

Questions?

Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

Principal Display Panel - 177 Ml Bottle Label

treats

prosoriä

medicated
shampoo

selenium sulfide 1%

anti-dandruff
anti-seborrheic

6 FL OZ (177 mL)

Principal Display Panel (177 mL Bottle Label)

Principal Display Panel (177 mL Bottle Label)

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