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| Product NDC Code | 82575-110 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Acne body wash |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SOAP | ||||||||
| RxCUI drug identifier | 562600 | ||||||||
| Application Number | M006 | ||||||||
| Labeler Name | Curology | ||||||||
| Packages |
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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 Dampen skin and massage a thin layer onto the entire affected area then rinse thoroughly. 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, Cocamidopropyl Dimethylamine, Polygiyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Hydroxypropyl Methylcellulose, Phenoxyethanol, Sodium Chloride, Zinc Pyrithione, Sodium Hydroxide, Polyquaternium-7, Ethylhexylglycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sodium Benzoate
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 Body Wash Salicylic Acid Salicylic Acid Salicylic Acid Water Sodium C14-16 Olefin Sulfonate Glycerin Cocamidopropyl Betaine Cocamidopropyl Dimethylamine Hypromellose, Unspecified Polyglyceryl-4 Caprate Polyglyceryl-6 Caprylate Phenoxyethanol Pyrithione Zinc Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 MW) Ethylhexylglycerin Sodium Hydroxide Edetate Disodium Anhydrous Tea Tree Oil Sodium Chloride Edetic Acid Sodium Benzoate Formaldehyde/Sodium Naphthalenesulfonate Copolymer (3000 MW) Xanthan Gum Magnesium Nitrate Methylchloroisothiazolinone Magnesium Chloride Methylisothiazolinone
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 – 100 mL Tube Label Curology Acne Body Wash 2% Salicylic Acid Acne Treatment with clarifying tea tree oil DERMATOLOGIST FOUNDED•DEVELOPED•TESTED 100 ml/3.4 fl oz Principal Display Panel – 100 mL Tube Label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at 20°-25°C (68°-77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 858-859-1188
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 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. 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