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| Product NDC Code | 82721-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pain be gone |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M014 | ||||||
| Labeler Name | Back to Earth Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 9.6%
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.■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. ■ Children under 2 years of age: consult a Physician/Doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin, Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens (Wintergreen) Oil, Cinnamomum Camphora (White) Oil, Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.
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 the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. For penetrating pain relief.
Purpose
Information about the drug product’s indications for use.Pain Relieving Gel
Spl product data elements
Usually a list of ingredients in a drug product.Pain Be Gone Menthol CAPRYLHYDROXAMIC ACID GLYCERIN CITRUS LIMON FRUIT OIL MENTHOL MENTHOL ROSMARINUS OFFICINALIS FLOWERING TOP OIL EUCALYPTUS OIL GAULTHERIA PROCUMBENS LEAF WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYL SALICYLATE ARNICA MONTANA CAMPHOR OIL, WHITE PINE NEEDLE OIL (PINUS SYLVESTRIS) POLYSORBATE 80 CAPRYLYL GLYCOL GLYCERYL CAPRYLATE MENTHA PIPERITA
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
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. In case of overdose, get medical help or contact a Poison Control Center right away.
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. ■ Avoid Contact with the eyes. If conditions worsen, or if symptoms persist for more that 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician/doctor. ■ Do not apply to wounds or damaged skin. ■ Do not bandage tightly. ■ Keep out of reach of children. In case of overdose, 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