Dermacleanse Acne Spot Treatment Gel
FDA Label NDC 83313-0062

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zenmed Raging Creations Ltd. for the product Dermacleanse Acne Spot Treatment (NDC 83313-0062). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

FOR EXTERNAL USE ONLY. 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 MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. ASK A DOCTOR OR PHARMACIST BEFORE USE ON CHILDREN. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH CARE PROFESSIONAL BEFORE USE.

Active Ingredient

SALICYLIC ACID 2.0%

Purpose

ACNE TREATMENT GEL.

Use

FOR THE TREATMENT OF ACNE. REDUCES SEVERITY OF ACNE BLEMISHES. ALLOWS SKIN TO HEAL. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Directions

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONCE DAILY BEFORE BED. 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

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

WATER, ALCOHOL (ETHANOL), GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER (AND) ALCOHOL, HYDROXYETHYLCELLULOSE, GLYCERIN (AND) SPIRAEA ULMARIA EXTRACT, ZINC SULFATE, AND GLYCOLIC ACID.

Principal Display Panel - 30 Ml Bottle Label

DERMACLEANSE™
Acne Spot Treatment Gel

Maximum Strength to
Fight Acne Fast &
Prevent Skin Damage

Pore Clearing Formula
with Meadowsweet
& Glycolic Acid

VEGAN,
PLANT-BASED

CRUELTY-FREE
CERTIFIED

30 ml | 1 oz

ZENMED
Reconstructive Skincare

24m

Principal Display Panel (30 ml Bottle Label)

Principal Display Panel (30 ml Bottle Label)

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