Acne Solutions Gel
FDA Label NDC 49527-825

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinique Laboratories Llc for the product Acne Solutions (NDC 49527-825). 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, indications & usage, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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:    SALICYLIC ACID 0.5%

Otc - Purpose

PURPOSE:  ACNE TREATMENT

USE:  FOR THE TREATMENT OF ACNE

CLEARS UP ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

Indications & Usage

INDICATIONS: FOR THE TREATMENT OF ACNE

Warnings

WARNINGS: FOR EXTERNAL USE ONLY. 

Otc - When Using

WHEN USING THIS PRODUCT: USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR RIGHT AFTER 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.

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.

Dosage & Administration


DIRECTIONS
  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING
  • COVER THE ENTIRE AFFECTED AREA WITH ONE APPLICATION
  • GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

Inactive Ingredient

inactive ingredients: alcohol denat. [] water\aqua\eau [] acrylates/c10-30 alkyl acrylate crosspolymer [] hamamelis virginiana (witch hazel) [] laminaria saccharina extract [] sea whip extract [] butylene glycol [] benzalkonium chloride

Package Label.Principal Display Panel

principal display panel:


clinique

ACNE SOLUTIONS

SPOT HEALING GEL

SALICYLIC ACID

ACNE MEDICATION


ALL SKIN TYPES


0.5 FL.OZ LIQ./50 ML


CLINIQUE LABORATORIES INC, DISTR

NEW YORK, NY 10022

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