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| Product NDC Code | 63940-082 | ||||
|---|---|---|---|---|---|
| Drug Name | Harmon face values oil-free body wash salicylic acid acne treatment pink grapefruit |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | part358B | ||||
| Labeler Name | HARMON STORES, INC. | ||||
| Packages |
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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, glycerin, cocamidopropyl betaine, acrylates copolymer, cocamidopropyl PG-dimonium chloride phosphate, polyquaternium-7, citrus grandis (grapefruit) fruit extract, anthemis nobilis flower extract (roman chamomile), camellia sinensis leaf extract (green tea), chondrus crispus powder (carrageenan), agar, neopentyl glycol dicaprylate/dicaparate, sodium ascorbyl phosphate (vitamin C phosphate), propylene glycol, C12-15 alkyl lactate, polysorbate 20, butylene glycol, polyvinyl alcohol, potassium chloride, phenethyl alcohol, PPG-2 methyl ether, disodium EDTA, sodium chloride, sodium hydroxide, benzlkonium chloride, sodium benzotriazolyl butylphenol sulfonate, fragrance, mica, titanium dioxid, iron oxides, red 30, 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.Harmon Face Values Oil-Free Body Wash Salicylic Acid Acne Treatment Pink Grapefruit SALICYLIC ACID POLYVINYL ALCOHOL, UNSPECIFIED WATER SODIUM C14-16 OLEFIN SULFONATE GLYCERIN COCAMIDOPROPYL BETAINE COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) PUMMELO CHAMAEMELUM NOBILE FLOWER GREEN TEA LEAF CHONDRUS CRISPUS AGAR NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE SODIUM ASCORBYL PHOSPHATE PROPYLENE GLYCOL C12-15 ALKYL LACTATE POLYSORBATE 20 BUTYLENE GLYCOL POTASSIUM CHLORIDE PPG-2 METHYL ETHER EDETATE DISODIUM SODIUM CHLORIDE SODIUM HYDROXIDE BENZALKONIUM CHLORIDE SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE MICA TITANIUM DIOXIDE FERRIC OXIDE RED FD&C RED NO. 40 D&C RED NO. 30 EXT. D&C VIOLET NO. 2 SALICYLIC ACID SALICYLIC ACID PHENYLETHYL ALCOHOL
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.Label 42537E1-F3
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