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Product NDC Code | 64657-003 | ||||||
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Drug Name | Prickly pear and salicylic acid acne clearing tonic |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 251577 | ||||||
Application Number | M006 | ||||||
Labeler Name | Naturopathica Holistic Health | ||||||
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 Shake well before use. Cleanse skin thoroughly before applying this product. Dispense onto cotton pad and sweep over face, neck and chest. Avoid immediate eye area. Do not rinse. 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 (Aqua), Aloe Barbadensis Leaf Juice , Glycolic Acid, Sorbitan Oleate Decylglucoside Crosspolymer, Gluconolactone, Dimethyl Isosorbide, Sodium PCA, Glycerin, Sodium Benzoate, Betaine, Citrus Limon (Lemon) Peel Oil, Hibiscus Sabdariffa Flower Extract, Opuntia Ficus-Indica Stem Extract, Sodium Hyaluronate, Calcium Gluconate , Chlorophyllin-Copper Complex, Rosmarinus Officinalis (Rosemary) Leaf Oil , Mentha Viridis (Spearmint) Leaf Oil , Sodium Hydroxide , Limonene.
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 management of acne. Penetrates pores to eliminate most acne blemishes.
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.PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC Salicylic Acid WATER ALOE VERA LEAF GLYCOLIC ACID GLUCONOLACTONE DIMETHYL ISOSORBIDE SODIUM PYRROLIDONE CARBOXYLATE GLYCERIN SODIUM BENZOATE BETAINE LEMON OIL, COLD PRESSED HIBISCUS SABDARIFFA FLOWER OPUNTIA FICUS-INDICA STEM HYALURONATE SODIUM CALCIUM GLUCONATE SODIUM COPPER CHLOROPHYLLIN ROSEMARY OIL SPEARMINT OIL SODIUM HYDROXIDE LIMONENE, (+)- 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.PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton NATUROPATHICA ® FOR DEEPER BEAUTY PRICKLY PEAR & SALICYLIC ACID ACNE CLEARING TONIC 5 FL OZ / 150 ML PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton
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.Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
Distributed by: Naturopathica Holistic Health New York, NY 10001.
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 646-979-3997
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor If irritation becomes severe.
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 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not use if you have very sensitive skin or are sensitive to Salicylic Acid. skin irritation and dryness may occur if you use another topical acne medication at the same time or immediately following. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at Room Temperature. Keep out of direct sunlight after use. Do not freeze.
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 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not use if you have very sensitive skin or are sensitive to Salicylic Acid. skin irritation and dryness may occur if you use another topical acne medication at the same time or immediately following. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor. Stop use and ask a doctor If irritation becomes severe. 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