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Product NDC Code | 80818-246 | ||||
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Drug Name | Canafarma spot on acne treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 317152 | ||||
Application Number | M006 | ||||
Labeler Name | Canafarma Corp. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Salicylic Acid 2.0% PURPOSE Acne Treatment
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: Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer 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: Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (European Hemp) Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, DMAE Bitartrate, Dimethicone, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hydrogen Peroxide, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polysorbate-20, Retinol (Vitamin A), Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sodium PCA, Sodium Pyrophosphate, Tocopheryl Acetate (Vitamin E), Xanthan Gum
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. Penetrates pores to clear most acne blemishes, acne pimples, blackheads, or whiteheads.
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.CANAFARMA Spot On Acne Treatment SALICYLIC ACID ALLANTOIN ALOE VERA LEAF WATER BUTYLENE GLYCOL SHEA BUTTER CANNABIS SATIVA FLOWERING TOP CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETYL ALCOHOL CHAMOMILE DEANOL BITARTRATE DIMETHICONE FUCUS VESICULOSUS GLYCERIN LICORICE HYDROGEN PEROXIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) TEA TREE OIL PEPPERMINT OIL METHYLISOTHIAZOLINONE POLYSORBATE 20 RETINOL SALIX ALBA BARK SODIUM HYDROXIDE SODIUM PYRROLIDONE CARBOXYLATE SODIUM PYROPHOSPHATE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM 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.Package Labeling: Bottle2
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
OTHER INFORMATION: Protect the product in this container from excessive heat and direct sun.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? 1-800-871-7143
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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If pregnant, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.
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. If pregnant, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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