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| Product NDC Code | 51326-938 | ||||
|---|---|---|---|---|---|
| Drug Name | Gly-sal 10-2 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1048903 | ||||
| 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 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 Spray the entire affected area of the body one to three times daily. 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 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 Acetone, Ammonium Hydroxide, Disodium EDTA, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Imidazolidinyl Urea, Polysorbate-20, Purified Water, SD Alcohol 40B (13% v/v) Sodium Benzoate
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 For the treatment of acne of the body, with the skin enhancement properties of glycolic acid
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.Gly-Sal 10-2 Salicylic Acid SALICYLIC ACID SALICYLIC ACID GLYCOLIC ACID GREEN TEA LEAF COCAMIDOPROPYL BETAINE EDETATE DISODIUM 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 FD&C YELLOW NO. 5 ZINC PIDOLATE
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 - 89 ml Bottle Label COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC Gly/Sal 10-2 Spray Glycolic Acid 10% Salicylic Acid USP, 2% Net 3 fl. oz. (89 ml) Available Custom Branded 800.445.2595 [email protected] PRINCIPAL DISPLAY PANEL - 89 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 reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately. Flammable; keep tightly closed, away from flame and heat. Sunscreen use is recommended with any Glycolic Acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.
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. Direct spray away from face, especially eyes, lips and mouth. If irritation develops, discontinue use and consult a doctor. Using other topical acne medication 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. Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately. Flammable; keep tightly closed, away from flame and heat. 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