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| Product NDC Code | 82753-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Supersmooth acne clear 5 min mask |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M006 | ||||||
| Labeler Name | GLAMGLOW LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1.0%
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 As a cleansing scrub, massage gently over wet skin avoiding eye area; rinse with water Because excessive drying of the skin may occur, start with one use daily, then gradually increase to twice daily, or as directed by a doctor If bothersome dryness or peeling occurs, reduce use to once a day or every other day As a 5 minute mask (one to two times per week), apply a thin layer over the face or affected areas, avoiding eye area; rinse with water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER\AQUA\EAU • KAOLIN • GLYCERIN • BUTYLENE GLYCOL • MAGNESIUM ALUMINUM SILICATE • GLYCERYL STEARATE • PEG-100 STEARATE • SILICA • SODIUM LAUROYL SARCOSINATE • TOCOPHERYL ACETATE • CHARCOAL POWDER • ACETYL GLUCOSAMINE • SUCROSE • GENTIANA LUTEA (GENTIAN) ROOT EXTRACT • LAMINARIA SACCHARINA EXTRACT • XANTHAN GUM • SODIUM HYDROXIDE • CAPRYLYL GLYCOL • 1,2-HEXANEDIOL • ALLYL METHACRYLATES CROSSPOLYMER • FRAGRANCE (PARFUM) • LINALOOL • DISODIUM EDTA • TETRASODIUM EDTA • PHENOXYETHANOL • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77499) <ILN49835>
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.Use For the treatment of acne Helps clear acne blemishes Helps prevent development of new acne blemishes
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.SUPERSMOOTH ACNE CLEAR 5 MIN MASK SALICYLIC ACID WATER KAOLIN GLYCERIN BUTYLENE GLYCOL MAGNESIUM ALUMINUM SILICATE GLYCERYL MONOSTEARATE PEG-100 STEARATE SILICON DIOXIDE SODIUM LAUROYL SARCOSINATE .ALPHA.-TOCOPHEROL ACETATE ACTIVATED CHARCOAL N-ACETYLGLUCOSAMINE SUCROSE GENTIANA LUTEA ROOT SACCHARINA LATISSIMA XANTHAN GUM SODIUM HYDROXIDE CAPRYLYL GLYCOL 1,2-HEXANEDIOL ALLYL METHACRYLATE LINALOOL, (+/-)- EDETATE DISODIUM ANHYDROUS PHENOXYETHANOL TITANIUM DIOXIDE FERROSOFERRIC OXIDE SALICYLIC ACID SALICYLIC ACID
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 - 125 ml Tube Label SUPERSMOOTH™ ACNE CLEARING 5-MINUTE MASK TO SCRUB HOLLYWOOD, CALIFORNIA GLAMGLOW ® ★ CLEAR ★ SMOOTH ★ REFINE ★ 4.2 FL. OZ. LIQ/125 ml ℮ PRINCIPAL DISPLAY PANEL - 125 ml Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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. If swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs, use only one topical acne medication at a time.
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 When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs, use only one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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