Iblanc Restora-bright
FDA Label NDC 52960-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Iblanc Inc. for the product Iblanc Restora-bright (NDC 52960-101). 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 indications & usage, otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, inactive ingredient, 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

Indications & Usage

USES: FOR THE TREATMENT OF ACNE

Otc - Active Ingredient

Active Ingredient:   Benzoyl Peroxide 5.25%

Otc - Purpose

Uses

  • for the treatment of acne

Warnings

Warnings

For external use only

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.

Otc - Do Not Use

Do not use if you

  • have very sensitive skin.
  • are sensitive to benzoyl peroxide

Otc - When Using

When using this product

  • avoid unnecessary skin exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth.  If eye contact accidentally occurs, rinse eyes throughly with water.
  • 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.

    • Stop use and ask a doctor if irritation becomes severe.

Inactive Ingredient

Inactive Ingredients Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder, Acrylates/C13-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Package Label.Principal Display Panel

IBlanc DermaceuticalsRESTORA-BRIGHTACNE-HEALINGCREAM

Dosage & Administration

APPLY A THIN LAYER TO BLEMISHES DAILY AFTER CLEANSING SKIN. IF NEEDED AND NO DRYNESS OR PEELING OCCURS, USE FOR TOUCH-UP THROUGHOUT THE DAY.

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