DERMACLEANSE- salicylic acid gel

DERMACLEANSE by

Drug Labeling and Warnings

DERMACLEANSE by is a Otc medication manufactured, distributed, or labeled by ZENMED Raging Creations Ltd., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SALICYLIC ACID 2.0%

PURPOSE

ACNE TREATMENT GEL.

INDICATIONS

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

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.

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.

KEEP OUT OF REACH OF CHILDREN.

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

INGREDIENTS AND APPEARANCE

DERMACLEANSE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83313-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM GLYCOLATE (UNII: B75E535IMI)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
PANTOTHENIC ACID (UNII: 19F5HK2737)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83313-0004-6	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	04/01/2023

Labeler - ZENMED Raging Creations Ltd. (203762150)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(83313-0004)