Proactiv Blackhead Dissolving Gel
FDA Label NDC 11410-024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alchemee, Llc for the product Proactiv Blackhead Dissolving (NDC 11410-024). 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, when using this product, stop use and ask a doctor, 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

Other

Drug Facts

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

Manfuactured in Canada
Proactiv is a trademark of the Proactiv Company Sàrl.

Active Ingredient

Salicylic acid 0.5%

Purpose

Acne treatment

Use

for the management of acne                 

Warnings

For external use only

When Using This Product

  • 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.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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.

Directionsas A Mask:

  • Sensitivity Test for a New User:  Apply product sparingly to one or two small affected areas during the first 3 uses.  If no discomfort occurs, follow the directions stated below.
  • Apply over clean face and neck.  Massage with light circular movements until the gel liquefies on contact with the skin.  Leave on for up to five minutes.  Rinse thoroughly with warm water.  Pat dry.  Use 1 - 2 times per week.
  • If using with other acne products limit to 1 time per week.
  • If bothersome dryness or peeling occurs, reduce frequency of application.

Inactive Ingredients

water, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, camellia sinensis leaf extract, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, bisabolol, lactic acid, caprylyl glycol, ethylhexylglycerin, PEG-40 hydrogenated castor oil, polyisobutene, hexylene glycol, polysorbate 20, PPG-26-buteth-26, butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, ethylhexyl salicylate, phenoxyethanol, fragrance.

Questions Or Comments?

Within US 1-800-950-4695

Principal Display Panel - 30 Ml Tube Box

proactiv®

BLACKHEAD
DISSOLVING GEL

1 FL. OZ. 30 mL

salicylic acid acne medication

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