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| Product NDC Code | 41250-043 | ||||
|---|---|---|---|---|---|
| Drug Name | Body |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 1431703 | ||||
| Application Number | part348 | ||||
| Labeler Name | Meijer Distribution, Inc | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions DISTRIBUTED BY MEIJER DISTRIBUTION, INC GRAND RAPIDS, MI 49544 www.meijer.com
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 0.15%
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 2 year of age and older - apply to affected area not more than 3 to 4 times daily children under 2 years of age - do not use, consult a doctor for best results dry skin thoroughly before applying
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Zea mays (corn) starch. sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate
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 temporary relief of pan and itching due to: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, poison sumac
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Body Menthol MENTHOL MENTHOL STARCH, CORN SODIUM BICARBONATE TRICALCIUM PHOSPHATE ZINC OXIDE GUM TALHA EUCALYPTOL METHYL SALICYLATE SALICYLIC ACID THYMOL ZINC STEARATE
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 Meijer MEDICATED BODY POWDER External Analgesic TRIPLE BENEFITS Itch Relief Cooling Absorbent Pain Relieving Powder Menthol 0.15% This product does not contain talc NET WT 10 OZ (283 g) image description
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.disclaimers This product is sold by weight, not by volume. Some settling may occur during handling and shipping
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.
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, or if symptoms persist for more than 7 days or clear up and occur again within a few days
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 the eyes
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
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