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| Product NDC Code | 72204-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Patchology breakout box 3-in-1 acne treatment |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1994404 | ||||
| Application Number | M006 | ||||
| Labeler Name | Iontera, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient(s) Salicylic Acid 0.5%
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 Cleanse thoroughly before applying medication. Apply the sticker on the affected areas. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dyrness or peeling occurs, reduce application to once a day or every other day. Sensitivity test for a new user: Apply product to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates Copolymer, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Water (Aqua/Eau), Alcohol Denat., Melaleuca Alternifolia (Tea Tree) Leaf Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Volcanic Ash, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Butylene Glycol, Phytosphingosine, Phenoxyethanol, Polysorbate 80, PVP.
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 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.PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT SALICYLIC ACID BLEMISH SHRINKING SALICYLIC ACID DOTS SALICYLIC ACID PHYTOSPHINGOSINE PHENOXYETHANOL POLYSORBATE 80 POVIDONE SALICYLIC ACID SALICYLIC ACID BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) ALCOHOL EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP HYALURONATE SODIUM VITIS VINIFERA SEED BUTYLENE GLYCOL WATER TEA TREE OIL SODIUM METABISULFITE BISULFITE ION DETOXIFYING CHARCOAL NOSE STRIPS HAMAMELIS VIRGINIANA TOP COPOVIDONE K25-31 BENTONITE ACTIVATED CHARCOAL POVIDONE, UNSPECIFIED WATER GLYCERIN POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE KAOLIN PHENOXYETHANOL BUTYLENE GLYCOL POTASSIUM SORBATE 1,2-HEXANEDIOL ALOE VERA LEAF MENTHOL SODIUM HYDROXIDE SODIUM DEHYDROACETATE GLYCYRRHIZINATE DIPOTASSIUM ABSORBING HYDROCOLLOID DOTS CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYISOBUTYLENE (1000 MW) POLYBUTENE (1400 MW)
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.Product Packaging breakout box rev
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Company Information DIST. BY RARE BEAUTY BRANDS, INC. NORWOOD, MA 02062 DESIGNED IN THE USA MADE IN KOREA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are allergic to the dressing or to any of the components.
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.
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? Call toll free 1-888-243-0646 24/7, 365 Report serious adverse reactions to: 83 Morse St. Suite 8A Norwood, MA 02062
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 likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used.
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 likely to occur if you use another topical acne product at the same time. If irritation occurs, only one medication should be used. Do not use if you are allergic to the dressing or to any of the components. 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