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Product NDC Code | 83313-0004 | ||||
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Drug Name | Dermacleanse |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 346298 | ||||
Application Number | M006 | ||||
Labeler Name | ZENMED Raging Creations Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT SALICYLIC ACID 2.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS PURIFIED WATER, WITCH HAZEL DISTILLATE, VEGETABLE GLYCERIN, HYDROXYETHYLCELLULOSE, SODIUM GLYCOLATE, SPIRAEA ULMARIA EXTRACT, VITAMIN B5, METHYLISOTHIAZOLINONE, CHLORHEXIDINE GLUCONATE.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS FOR THE TREATMENT OF ACNE. REDUCES SEVERITY OF ACNE BLEMISHES. ALLOWS SKIN TO HEAL. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.
Purpose
Information about the drug product’s indications for use.PURPOSE ACNE TREATMENT GEL.
Spl product data elements
Usually a list of ingredients in a drug product.DERMACLEANSE SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID WATER HAMAMELIS VIRGINIANA TOP WATER HYDROXYETHYL CELLULOSE, UNSPECIFIED SODIUM GLYCOLATE FILIPENDULA ULMARIA FLOWER PANTOTHENIC ACID METHYLISOTHIAZOLINONE CHLORHEXIDINE GLUCONATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 PRINCIPAL DISPLAY PANEL - 30 ml Tube Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API