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Salicylic acid - Medication Information

Product NDC Code 80861-117
Drug Name

Salicylic acid

Type Generic
Active Ingredients
Salicylic acid .02 g/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 562600
Application Number M006
Labeler Name Acne Free, LLC
Packages
Package NDC Code Description
80861-117-01 1 g in 1 tube (80861-117-01)
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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 wet hands and face • squeeze scrub into hands and rub together • apply to face and massage gently, avoiding contact with eyes. If contact occurs, rinse thoroughly with water. • rinse face

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients water, cocamidopropyl betaine, sodium cocoyl isethionate, glycerin, coco-glucoside, hydrogenated castor oil, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, sodium benzoate, avena sativa (oat) kernel oil, guar hydroypropyltrimonium chloride, hydrogenated jojoba oil, zingiber of cinale (ginger) root juice, charcoal powder, iron oxides (CI 77499)

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 Use for the treatment of acne

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Salicylic Acid Salicylic Acid SALICYLIC ACID SALICYLIC ACID COCAMIDOPROPYL BETAINE

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.
Exfoliating Scrub

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

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? 1-888-768-2913

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 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.

Precautions

Information about any special care to be exercised for safe and effective use of the drug.
Avoid contact with eyes Avoid contact with the eyes. It contact occurs, ush thoroughly with water.

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 When using this 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. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes Avoid contact with the eyes. It contact occurs, ush thoroughly with water.

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