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Gly-sal 10-2 pads - Medication Information

Product NDC Code 51326-039
Drug Name

Gly-sal 10-2 pads

Type Brand
Active Ingredients
Salicylic acid .02 g/1
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 797892
Application Number M006
Labeler Name Topiderm, Inc.
Packages
Package NDC Code Description
51326-039-60 60 cloth in 1 jar (51326-039-60)
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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 Wipe the entire affected area with a moist pad 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 Purified Water, Glycolic Acid, SD Alcohol 40B(13% v/v), Hamamelis Virginiana (Witch Hazel) Water, Ammonium Hydroxide, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Acetone, Disodium EDTA.

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 Cleansing pads for the treatment of acne, 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 Pads Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER GLYCOLIC ACID ALCOHOL HAMAMELIS VIRGINIANA TOP WATER AMMONIA POLYSORBATE 20 SODIUM BENZOATE IMIDUREA ACETONE EDETATE DISODIUM ANHYDROUS

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 - 60 Pad Jar Label REPLENiX ® ACNE SOLUTIONS Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 Gly/Sal ® 10-2 Pads Glycolic Acid 10% Salicylic Acid USP, 2% 60 Pads PRINCIPAL DISPLAY PANEL - 60 Pad Jar 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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
If irritation develops, discontinue use and consult a doctor.

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. 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