Acne Defense Spot Treatment Gel
FDA Label NDC 57627-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics, Inc for the product Acne Defense Spot Treatment (NDC 57627-201). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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:                             Purpose

Salicylic Acid 2.0%                             Acne Treatment

Otc - Purpose

For the treatment of Acne

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

Indications & Usage

Using other topical acne medication at the same tim or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

Warnings

  • For external use only

Dosage & Administration

Cleanse skin thoroughly before applying. Cover the entire affected area with a thing layer 1 to 3 times daily or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

SD Alcohol 40-B, Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Polyacrylate Crosspolymer 6, Laminaria Saccarina Extract, Thermus Thermophillus Ferment, Opuntia Ficus-Indica Stem Extract, Sea Whip Extract, Bisabolol, Glycerin, Pentylene Glycol, Butylene Glycol, Propylene Glycol, Aminomethyl Propanol, 4-t-Butylcyclohexanol, Hydroxyethylcellulose, Hydroxymethoxyphenyl Decanone, Benzalkonium Chloride

Package Label.Principal Display Panel

ACNE DEFENSE

SPOT TREATMENT

ACNE TREATMENT GEL   

merle norman

14g e

NET WT. .50 OZ.

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