Proactiv Advanced Daily Oil Control Lotion
FDA Label NDC 11410-055

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 Advanced Daily Oil Control (NDC 11410-055). 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, use, warnings, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment gel

Use

for the management of acne

Warnings

For external use only

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 toptical acne medication at a time.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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, follow the directions stated below.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer 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, alcohol denat., butylene glycol, cyclopentasiloxane, glyceryl stearate, PEG-100 stearate, nylon-12, PVM/MA decadiene crosspolymer, aluminum starch octenylsuccinate, cyclohexasiloxane, decylene glycol, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol, sarcosine, xanthan gum, hexylene glycol, sodium hydroxide, disodium EDTA, caprylyl glycol, pentylene glycol, phenoxyethanol, fragrance

Questions or comments?
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Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd
El Segundo, CA 90245 ● proactiv.com
Made in the USA of foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

Principal Display Panel - 22 Ml Carton

 
proactiv®                     

ADVANCED
DAILY OIL
CONTROL

0.75 FL. OZ. 22 mL

salicylic acid acne medication           

Principal Display Panel - 75 Ml Carton

proactiv®  

ADVANCED
DAILY
OIL CONTROL

2.5 FL. OZ. 75 mL

salicylic acid acne medication

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