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| Product NDC Code | 63550-193 | ||||
|---|---|---|---|---|---|
| Drug Name | Blemish |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 308694 | ||||
| Application Number | part333D | ||||
| Labeler Name | Kamins Dermatologics Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient: Benzoyl Peroxide: 5%
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 Clean the skin thoroughly befor applying. Cover the entire affected area with a thin layer 1 to 3 times daily. because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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. If going outside, use a sunscreen. Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: water, alcohol denat., acer saccharum (maple isolate), disodium PEG-12 dimethicone sulfosuccinate, carbomer, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid
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.A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots. Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry. Uses ■ Helps treat acne. ■ Dries up acne pimples. ■ Helps prevent new acne pimples.
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.Blemish Benzoyl peroxide WATER ACER SACCHARUM SAP DIMETHICONE SODIUM HYDROXIDE PHENOXYETHANOL CAPRYLYL GLYCOL SORBIC ACID BENZOYL PEROXIDE BENZOYL PEROXIDE
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.B. KAMINS BLEMISH GEL 5% 30mL / 1.7 fl.oz DIN 02248217 Blemish front panel image
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. Do not use on broken skin. large areas of the body. When using this product, Apply to affected areas only avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes/eye area, lips, mouth and nostrils. If contact occurs, rinse thoroughly with water. This product may bleach hair or dyed fabrics. Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor. Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases. If swallowed, seek medical assistance or contact a Poison Control Center immediately.
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