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Salicylic acid - Medication Information

Product NDC Code 36800-875
Drug Name

Salicylic acid

Type Brand
Active Ingredients
Salicylic acid 5 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 199308
Application Number M006
Labeler Name TOPCO ASSOCIATES LLC
Packages
Package NDC Code Description
36800-875-34 237 ml in 1 bottle, plastic (36800-875-34)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 0.5%

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 before applying this product cover the entire affected area with a thin layer and rinse thoroughly one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol (24.5%), algae extract, aloe barbadensis leaf extract, benzophenone-4, denatonium benzoate, dimethicone propyl PG-betaine, fragrance, glycerin, isoceteth-20, PEG-32, propylene glycol, sodium citrate, water, blue 1

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.
Use 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.
Salicylic Acid Astringent ALCOHOL ALOE BENZOPHENONE DENATONIUM BENZOATE DIMETHICONE GLYCERIN ISOCETETH-20 POLYETHYLENE GLYCOL 1500 SODIUM CITRATE WATER FD&C BLUE NO. 1 SALICYLIC ACID SALICYLIC 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 TopCare beauty DEEP CLEANING ASTRINGENT Salicylic Acid Acne Medication Compare to CLEAN & CLEAR Gentle formula that treats & helps prevent pimples Sensitive Skin 8 FL OZ (237 mL) image description

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.
*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Sensitive Skin Deep Cleaning Astringent. Visit us here for more information: http://topbrands.com DISTRIBUTED BY TOPCO ASSOCIATES LLC 150 NORTHEST POINT BOULEVARD ELK GROVE VILLAGE, IL 60007 1-888-423-0139 TOPCO VIJA0119 topcare@ topco.com 875.002/875AD-AE

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, get medical help or contact a Poison Control Center right away.

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 skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

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 Flammable. Keep away rom fire or flame.

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