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| Product NDC Code | 51326-928 | ||||
|---|---|---|---|---|---|
| Drug Name | Replenix gly-sal 10-2 cleanser |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 562600 | ||||
| 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 Salicylic Acid USP, 2%
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 Wet affected area, apply, and rinse well. Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician If bothersome dryness 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 Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.
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 Skin cleanser for the treatment of acne.
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.Replenix Gly-Sal 10-2 cleanser salicylic acid SALICYLIC ACID SALICYLIC ACID GREEN TEA LEAF COCAMIDOPROPYL BETAINE EDETATE CALCIUM DISODIUM GLYCOLIC ACID LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE POLYSORBATE 20 WATER FD&C RED NO. 40 SODIUM C12-15 ALKETH-15 SULFONATE SODIUM C14-16 OLEFIN SULFONATE TROLAMINE
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 - 200 ml Bottle Label REPLENiX ® ACNE SOLUTIONS Gly/Sal ® 10-2 Cleanser Glycolic Acid 10% Salicylic Acid USP, 2% Net 6.7 fl. oz. (200 ml) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 200 ml Bottle 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center.
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 Keep away from eyes, lips, and mouth. Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center. Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.
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