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Acne wash - Medication Information

Product NDC Code 63940-053
Drug Name

Acne wash

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 562600
Application Number M006
Labeler Name Harmon Stores Inc.
Packages
Package NDC Code Description
63940-053-54 269 ml in 1 bottle, pump (63940-053-54)
63940-053-61 59 ml in 1 bottle (63940-053-61)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Salicylic Acid 2.0%

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 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 application to once a day or every other day

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, sodium chloride, linoleamidopropyl PG-dimonium chloride phosphate, polysorbate 20, anthemis nobilis flower extract, citrus grandis (grapefruit) fruit extract, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, C12-15 alkyl lactate, cocamidopropyl PG-dimononium chloride phosphate, polyquaternium-7, ascorbyl palmitate, propylene glycol, sodium benzotriazolyl butylphenol sulfonate, PEG-120 methyl glucose dioleate, PEG-80 sorbitan laurate, disodium EDTA, benzalkonium chloride, fragrance, red 40, Ext. Violet 2

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.

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.
ACNE WASH SALICYLIC ACID WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE POLYSORBATE 20 CHAMAEMELUM NOBILE FLOWER PUMMELO ALOE VERA LEAF CHAMOMILE C12-15 ALKYL LACTATE COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) ASCORBYL PALMITATE PROPYLENE GLYCOL SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE PEG-120 METHYL GLUCOSE DIOLEATE PEG-80 SORBITAN LAURATE EDETATE DISODIUM BENZALKONIUM CHLORIDE FD&C RED NO. 40 EXT. D&C VIOLET NO. 2 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.
FACE VALUES OIL-FREE PINK GRAPEFRUIT FACIAL & BODY ACNE WASH 9.1 FL OZ (269mL) NDC 63940-053-54 FACE VALUES OIL-FREE PINK GRAPEFRUIT FACIAL & BODY ACNE WASH 2 FL OZ (59mL) NDC 63940-053-61 Label9.1 Label2

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 immediately.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information may stain some fabrics

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. • avoid contact with eyes. If contact occurs, flush 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

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