Listing For Clear-n-smooth Acne-pimple Medication

Listing For Clear-n-smooth Acne-pimple Medication
SPL v8
SPL
SPL Set ID 13c770df-63db-32d2-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.01 g)
Inactive Ingredients
Alcohol Water Propylene Glycol Sodium Bicarbonate Sulisobenzone Fd&c Blue No. 1 Dimethiconol (40 Cst) Edetate Disodium Levomenthol

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 1992-01-02

Description

For the Treatment of Acne Pimples

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

For the Treatment of Acne Pimples

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

Warnings

For External Use Only

Flammable. Keep away from open flame or fire.

When Using this Product

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by a doctor.
  • Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.
Active Ingredient

Salicylic Acid - 1.0%

Indications for Use

For the Treatment of Acne Pimples

Inactive Ingredients

alcohol, water, propylene glycol, dimethicone copolyol, disodium EDTA, benzophenone-4, menthol, sodium bicarbonate, blue #1, fragrance.

Instructions for Use

Cleanse the skin thoroughly before applying medication. Moisten a cotton ball with the lotion and 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.

Principal Display Panel

Keep Out of Reach of Children

For External Use Only. Keep Out of reach of Children.


Structured Label Content

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

Purpose

Acne Treatment

Warnings

For External Use Only

Flammable. Keep away from open flame or fire.

When Using this Product

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by a doctor.
  • Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.
Active Ingredient

Salicylic Acid - 1.0%

Indications for Use

For the Treatment of Acne Pimples

Inactive Ingredients

alcohol, water, propylene glycol, dimethicone copolyol, disodium EDTA, benzophenone-4, menthol, sodium bicarbonate, blue #1, fragrance.

Instructions for Use

Cleanse the skin thoroughly before applying medication. Moisten a cotton ball with the lotion and 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.

Principal Display Panel

Keep Out of Reach of Children

For External Use Only. Keep Out of reach of Children.


Advanced Ingredient Data


Raw Label Data

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