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Product NDC Code | 30400-506 | ||||
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Drug Name | Medicated body powder |
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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 | Jell Pharmaceuticals Pvt Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients 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 years of age and over, apply freely up to 3 or 4 times daily Children under 2 years: consult a physician for best results, dry skin thoroughly before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acacia seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, 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 the temporary relief of the pain and itch associated with minor cuts scrapes sunburn insect bites prickly heat rashes minor burns minor skin irritations dries the oozing of poison ivy, oak and 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.Medicated Body Powder MENTHOL SODIUM BICARBONATE TRICALCIUM PHOSPHATE ACACIA EUCALYPTUS OIL MENTHYL SALICYLATE, (+/-)- SALICYLIC ACID THYMOL ZINC STEARATE ZINC OXIDE ZEA MAYS WHOLE MENTHOL MENTHOL
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.Equate Medicated Body Powder Original Label
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 Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Redness, irritation, swelling or pain persist or increases symptoms do not get better within 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 usin this product Avoid contact with eyes. Not for genital area.
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