Acne Clearning Treatment
FDA Label NDC 51439-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carepluss Pharma S.a. De C.v. for the product Acne Clearning Treatment (NDC 51439-007). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient....................................PurposeSulphur 5%...............................................Acne medicationBenzoyl Peroxide 2.5%...............................Acme medicationSalicylic acid 2%........................................Acne medication

Otc - Purpose

Uses:For the management of acne
  • helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples
  • penetrates pores to reduce the number of acne pimples, white heads and black heads
  • help keep skin clear of new acne pimples, white heads and black heads
  • helps prevent new acne pimples, white heads and black heads from forming
  • help prevent the development of new pimples, white heads and black heads

Warnings

Warnings: For external use only.

Do not use
  • if you have sensitive skin and/or are sensitive to [active ingredient]
    • 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 sun screen, Acne Clearing Moisture with SPF 45
    • skin irritation may occur, characterized by redness, burning, itching, peeling, and 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

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.

Indications & Usage

Directions:
  • Acne Clearing Cleanser
  • Acne Clearing Tonic
  • Acne Clearing Treatment 101

Inactive Ingredient

Ingredients: Purified Water, Ethyl Alcohol, Hamammelis Extract, Chamomile Extract, Salicyl Alcohol, Ethhylene Glycol, Propylene Glycol, Dodecyl Benzene Sulfonate, EDTA, Methylparaben, Propylparaben. Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.

Dosage & Administration

Three Bottles
  • Acne Clearing Cleanser 240 mL
  • Acne Clearing Tonic 120 mL
  • Acne Clearing Treatment 101 60 mL

Package Label.Principal Display Panel

Acne Clearing Treatment - FACE

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