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Blemish spot treatment - Medication Information

Product NDC Code 83657-472
Drug Name

Blemish spot treatment

Type Brand
Active Ingredients
Salicylic acid .01 g/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 417424
Application Number M006
Labeler Name Skin Script, LLC
Packages
Package NDC Code Description
83657-472-01 15 g in 1 bottle, dispensing (83657-472-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Active Ingredients Salicylic Acid 1%

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 Directions · Clean the skin thoroughly before applying this product · Cover the entire affected area with a thin layer 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 skin care professional · 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 Inactive Ingredients Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Glycolic Acid, Coco-Caprylate/Caprate, Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Dicaprylyl Ether, Gluconolactone, Xanthan Gum, Sodium Benzoate, Lithium Magnesium Sodium Silicate, Acetyl Tributyl Citrate, Hamamelis Virginiana (Witch Hazel) Water, Fructooligosaccharides (D-beta), Alcohol, Glucosamine HCl (D), Phenyl t-Butylnitrone (Spin Trap), Citric Acid, Sodium Hydroxide

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 Uses For the treatment of acne. Dries and clears acne blemishes and allows skin to heal. Penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

Purpose

Information about the drug product’s indications for use.
Purpose Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Blemish Spot Treatment Salicylic Acid BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES CETOSTEARYL ALCOHOL GLYCERIN COCO-CAPRYLATE/CAPRATE CETEARYL GLUCOSIDE LAPONITE SODIUM BENZOATE WATER MEDIUM-CHAIN TRIGLYCERIDES DICAPRYLYL ETHER SODIUM HYDROXIDE GLUCOSAMINE HYDROCHLORIDE XANTHAN GUM GLYCOLIC ACID GLUCONOLACTONE ACETYLTRIBUTYL CITRATE WITCH HAZEL ALCOHOL SALICYLIC ACID SALICYLIC ACID GLYCERYL MONOSTEARATE PHENYL-N-TERT-BUTYLNITRONE CITRIC ACID ACETATE

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.
PDP

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
Correcting listing Uses section

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 Keep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Questions or comments? Skin Script™ Chandler, AZ 85226 www.skinscriptrx.com

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 Warnings For external use only 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. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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