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Product NDC Code | 80770-020 | ||||
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Drug Name | Natural 17 herbal splash |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | part348 | ||||
Labeler Name | NATURAL 17 | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol …………………………………………...………………….……... 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 Adults and Children over 12 years Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily. Children under 12 years of age: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Alcohol Denat, Water (Aqua), Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Fragrance (Parfum), Polysorbate 20, Mentha Arvensis Herb Oil, Thymus Vulgaris (Thyme) Oil, Aloe Barbadensis Leaf Extract, Glycerin, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronnellal, Linalool, Coumarin.
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.For temporary relief of minor pains on muscles and joints.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.NATURAL 17 HERBAL SPLASH MENTHOL POLYSORBATE 20 HYDROXYCITRONELLAL MENTHOL MENTHOL WATER ISOPROPYL ALCOHOL GERANIOL LINALOOL, (+)- COUMARIN EUCALYPTUS OIL .ALPHA.-AMYLCINNAMALDEHYDE PROPYLENE GLYCOL GLYCERIN .BETA.-CITRONELLOL, (R)- ALCOHOL BENZYL ALCOHOL BENZOIC ACID SORBIC ACID .ALPHA.-HEXYLCINNAMALDEHYDE MENTHA ARVENSIS LEAF OIL ALOE VERA LEAF THYME OIL
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.NATURAL 17 - HERBAL SPLASH NATURAL 17 - HERBAL SPLASH
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.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 tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
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 Condition worsens. Redness is present. Irritation develops. Symptoms persist for more than 7 days or clear up occur again within a few days. You experience signs injury, such as pain, swelling or blistering where the product was applied.
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.Use only as directed. Avoid contact with eyes and mucous membranes. If you experience an allergic reaction, discontinue use, and consult a physician. Do not expose the area treated with product to heat or direct sunlight.
Pregnancy or breast feeding
Pregnancy or Breast feedingAsk a health professional before use.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Extremely flammable Keep away from fire or flame.
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.For external use only. Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.
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