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| Product NDC Code | 64657-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Naturopathica chlorophyll and salicylic acid spot treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 346298 | ||||
| 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 On cleansed, completely dry skin, apply a thick, even layer directly on the blemish or blemished areas avoiding eye area, eyebrows, and hairline. Do not rub in. IN the morning or when product is dry to the touch, gently peel off starting from the outer edges of the spot. Rinse any residue with warm water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER (AQUA), PROPANEDIOL, ALOE BARBADENSIS LEAF JUICE, ALCOHOL, ALGIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, MALTODEXTRIN, BIXA ORELLANA SEED EXTRACT, GLYCERIN, NYMPHAEA CAERULEA FLOWER EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, MEDICAGO SATIVA (ALFALFA) EXTRACT, HYDROLYZED PEA PROTEIN, CARAMEL, CITRUS LIMON (LEMON) PEEL OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, SODIUM BENZOATE, POTASSIUM SORBATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT. CERTIFIED ORGANIC
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.NATUROPATHICA CHLOROPHYLL AND SALICYLIC ACID SPOT TREATMENT Salicylic Acid WATER PROPANEDIOL ALOE VERA LEAF ALCOHOL SODIUM ALGINATE HAMAMELIS VIRGINIANA TOP WATER MALTODEXTRIN BIXA ORELLANA SEED GLYCERIN NYMPHAEA CAERULEA FLOWER NELUMBO NUCIFERA FLOWER MEDICAGO SATIVA WHOLE CARAMEL LEMON OIL, COLD PRESSED ROSEMARY OIL SPEARMINT OIL SODIUM BENZOATE POTASSIUM SORBATE ROSEMARY 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 - 15 ML Tube Carton NATUROPATHICA ® FOR DEEPER BEAUTY CHLOROPHYLL & SALICYLIC ACID SPOT TREATMENT GEL ANTI- IMPERFECTIONS 0.5 FL OZ / 15 ML PRINCIPAL DISPLAY PANEL - 15 ML Tube 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.Distributed by: Naturopathica Holistic Health New York, NY 10001. Dublin, Ireland
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.
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