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| Product NDC Code | 80465-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Natureance body balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M017 | ||||
| Labeler Name | EROS GLOBAL CORP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Camphor 1%
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 Apply to 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), Glycerin, Polysorbate 20, Fragrance, Parfum, Arnica Montana Flower Extract, Cymbopogon Nardus (Citronella) Oil, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Benzyl Benzoate, Limonene, Benzyl Salicylate, Geraniol, Hexyl Cinnamal, Citral, Amyl Cinnamal, Citronellol, Linalool, Hydroxycitronellal, Eugenol, Farnesol.
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 temporary relief of pain.
Purpose
Information about the drug product’s indications for use.External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.NATUREANCE BODY BALM CAMPHOR .ALPHA.-HEXYLCINNAMALDEHYDE LINALOOL, (+/-)- HYDROXYCITRONELLAL FARNESOL .ALPHA.-AMYLCINNAMALDEHYDE BENZYL SALICYLATE .BETA.-CITRONELLOL, (R)- WATER CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) ALCOHOL GLYCERIN POLYSORBATE 20 ARNICA MONTANA FLOWER LIMONENE, (+/-)- FD&C BLUE NO. 1 CITRONELLA OIL FD&C YELLOW NO. 5 BENZYL BENZOATE GERANIOL CITRAL EUGENOL
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.NATUREANCE BODY BALM EROS GLOBAL BODY BALM
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.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.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.Avoid contact with eyes. Use only as directed. Do not apply to wounds or damaged, broken, or irritated skin. Do not bandage tightly or use with a heating pad If you experience an allergic reaction, discontinue use, and consult a physician.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast – feeding Ask a health professional before use.
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. · Ask a doctor before use if you have redness over affected area.
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