Dermacleanse™

Dermacleanse™
SPL v1
SPL
SPL Set ID 12f4ff55-e05b-4711-80d9-2d72cd4222a8
Route
TOPICAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 g)
Inactive Ingredients
Water Hamamelis Virginiana Top Water Hydroxyethyl Cellulose, Unspecified Sodium Glycolate Filipendula Ulmaria Flower Pantothenic Acid Methylisothiazolinone Chlorhexidine Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

SALICYLIC ACID 2.0%

Purpose

ACNE TREATMENT GEL.


Medication Information

Purpose

ACNE TREATMENT GEL.

Description

SALICYLIC ACID 2.0%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Warnings

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.

Directions

CLENSE 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.

Indications

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

Active Ingredient

SALICYLIC ACID 2.0%

Inactive Ingredients

PURIFIED WATER, WITCH HAZEL DISTILLATE, VEGETABLE GLYCERIN, HYDROXYETHYLCELLULOSE, SODIUM GLYCOLATE, SPIRAEA ULMARIA EXTRACT, VITAMIN B5, METHYLISOTHIAZOLINONE, CHLORHEXIDINE GLUCONATE.

Principal Display Panel 30 Ml Tube Label

DERMACLEANSE™

ACNE GEL

Rapid Acne

Clearing Formula

Formulated with BHA,

Meadowsweet Extract,

& Glycolic Acid

VEGAN,

PLANT-BASED

CRUELTY-FREE

CERTIFIED

30 ml | 1 fl oz

ZENMED®

Reconstructive Skincare


Structured Label Content

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Purpose (PURPOSE)

ACNE TREATMENT GEL.

Warnings (WARNINGS)

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.

Directions (DIRECTIONS)

CLENSE 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.

Indications (INDICATIONS)

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

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

PURIFIED WATER, WITCH HAZEL DISTILLATE, VEGETABLE GLYCERIN, HYDROXYETHYLCELLULOSE, SODIUM GLYCOLATE, SPIRAEA ULMARIA EXTRACT, VITAMIN B5, METHYLISOTHIAZOLINONE, CHLORHEXIDINE GLUCONATE.

Principal Display Panel 30 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 30 ml Tube Label)

DERMACLEANSE™

ACNE GEL

Rapid Acne

Clearing Formula

Formulated with BHA,

Meadowsweet Extract,

& Glycolic Acid

VEGAN,

PLANT-BASED

CRUELTY-FREE

CERTIFIED

30 ml | 1 fl oz

ZENMED®

Reconstructive Skincare


Advanced Ingredient Data


Raw Label Data

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