Aqua Plus Acne Treatment System
FDA Label NDC 71471-269

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Totally Clear Products, Inc for the product Aqua Plus Acne Treatment System (NDC 71471-269). 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 aqua plus acne treatment system, daily cleanser, active ingredients, purpose, uses, when using this product:, 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

Aqua Plus Acne Treatment System

Daily Cleanser

Drug Facts

Active Ingredients

Salicylic Acid 2.0%

Salicylic Acid 1.0%

Salicylic Acid 1.5%

Purpose

Acne Treatment

Acne Treatment

Acne Treatment

Uses

For The Treatment of Acne

For The Treatment Of Acne

For The Treatment Of Acne

When Using This Product:

  • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
  • 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.
  • Limit use to face and neck.

    • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
    • 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.
    • Limit use to face and neck.
      • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
      • 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.
      • Limits use to face and neck.

Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

  • If product is swallowed, get medical help or contact a Poison Control Center right away.
    • If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet your skin and massage the Aqua+ Daily Cleanser over your entire face, avoiding your eyes. Use the Aqua+ Daily Cleanser only once a day until your skin acclimates, after which you can move to twice-per-day applications. Rinse with water and gently pat your skin with a clean towel.

Clean the skin thoroughly before applying the Aqua+ Spotter Gel. 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.

Other Information

Store in a cool, dry place. Do not freeze.

Store in a cool, dry place. Do not freeze.

Store in a cool, dry place. Do not freeze.

Refreshing Toner

Drug Facts

Inactive Ingredient

Water, Propylene Glycol, SD Alcohol 40B, Cocamidopropyl Dimethylamine, Isoceteh-20, Salix Alba (Willow) Bark Extract, Methyl Gluceth-20, Caprylyl Glycol, Tetrasodium EDTA, Sodium Hydroxide, Phosphoric Acid, Hydrobromic Acid, Citric Acid, Glutaric Acid, Methlisothiazolinone

Water, Propylene Glycol, SD Alcohol 40B, Cocamidopropyl Dimethylamine, Butylene Glycol, Polyquaternium-10, Spirea ulmaria (Meadowsweet) Flower Extract, Triticum Vuldare (Wheat) Germ Extract, Tetrasodium ETDA, Caprylyl Glycol, Phosphoric Acid, Hydrobromic Acid, Citric Acid, Glutaric Acid, Methylisothiazolinone

Spotter Gel

Drug Facts

System Labeling

System Label (Aquaplus Box)

System Label (Aquaplus Box)

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