Proactiv Skin Purifying Mask Lotion
FDA Label NDC 11410-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Proactiv Company Llc for the product Proactiv Skin Purifying Mask (NDC 11410-013). 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, use, warnings, otc - when using, otc - do not use, otc - stop use, 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 The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ● Made in USA of Foreign and Domestic Component

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
 Manufactured in Canada ● proactiv.com

Proactiv is a trademark of The Proactiv Company Sàrl

Active Ingredient

Sulfur 6%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

Otc - When Using

When using this product

  • do not use this product more than three times per day.
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Otc - Do Not Use

Do not use on

  • broken skin
  • large areas of the skin

Otc - Stop Use

Stop use and ask a doctor if

  • irritation becomes severe.

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

  • Sensitivity Test for a New User:  Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follows the directions stated below.
  • apply a small amount to dampened skin.
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

water, kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, tocopherol, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, tetrasodium EDTA, sodium sulfate, butylene glycol, phenoxyethanol, fragrance, titanium dioxide, zinc oxide, chromium hydroxide green

Questions Or Comments?

Within US 1-800-950-4695

Principal Display Panel - 1 Oz.  28 G

proactiv®              

SKIN
PURIFYING
MASK                  

1 OZ. 28 g
sulfur acne medication

Principal Display Panel - 3 Oz. 85 G

proactiv®    

SKIN
PURIFYING
MASK 

3 OZ. 85 g
sulfur acne medication

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