Benzoil 12hr Acne Treatment
FDA Label NDC 71792-101

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 Skincare Company, Inc. for the product Benzoil 12hr Acne Treatment (NDC 71792-101). 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, otc - when using, 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.

Label Section Quick Index

Active Ingredient

BENZOYL PEROXIDE 3%

Purpose

ACNE TREATMENT

Use

FOR THE TREATMENT OF ACNE.

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT

  • SKIN IRRITATION AND DRYNESS IS 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 UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH.
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

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.
  • CLEAN 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.
  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A DOCTOR.

Other Information

  • ORGANIC INGREDIENTS ARE DENOTED WITH THE * SYMBOL
  • STORE AT 4-25°c (39-77°f), OUT OF DIRECT SUNLIGHT

Inactive Ingredients

ALCOHOL*, DIMETHYL ISOSORBIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL*, RICINUS COMMUNIS (CASTOR) SEED OIL*, WATER, XANTHAN GUM

Package Label.Principal Display Panel

Benzoil_uc (Benzoil Uc)

Benzoil_uc (Benzoil Uc)

* Please review the disclaimer below.