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| Product NDC Code | 51326-411 | ||||
|---|---|---|---|---|---|
| Drug Name | Replenix acne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 308694 | ||||
| Application Number | M006 | ||||
| Labeler Name | Topiderm, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl Peroxide, USP 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 Cleanse the skin thoroughly before applying. Apply a thin layer daily, then gradually increase to two or three times daily. If bothersome drying or peeling occurs, reduce applications. If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic 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.Uses Topical acne medication.
Purpose
Information about the drug product’s indications for use.Purpose Anti-acne
Spl product data elements
Usually a list of ingredients in a drug product.Replenix Acne Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER SODIUM HYDROXYMETHYLGLYCINATE SODIUM LAUROYL SARCOSINATE STEARIC 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 - 57 g Tube Label REPLENiX ® ACNE SOLUTIONS Acne Gel Benzoyl Peroxide USP, 5% Net wt. 2 oz. (57 g) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 57 g 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, seek professional assistance or contact a Poison Control Center immediately.
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 avoid unnecessary sun exposure and use a sunscreen.
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 When using this product avoid unnecessary sun exposure and use a sunscreen. For external use only. Keep away from eyes, lips, and mouth. If irritation develops, discontinue use and consult a doctor. 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, consult a doctor. May bleach fabrics. Keep out of reach of children. If swallowed, seek professional 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