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| Product NDC Code | 51367-032 | ||||
|---|---|---|---|---|---|
| Drug Name | Medicated balm arthritis pain relieving cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part348 | ||||
| Labeler Name | International Nature Nutraceuticals 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 Camphor 9% Menthol 16%
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 older: Apply to affected area 3-4 times daily Children under 2 years of age: Do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingreidents Eucalyptus oil Petrolatum Cinnamon bark oil Paraffin Ceresin Peppermint oil
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.Other Information Keep bottle tightly closed, store in a cool and dry place Do not use if seal is broken
Purpose
Information about the drug product’s indications for use.Uses The temporary relief of minor aches and pains of muscles and joints due to: Simple backache Sprains Bruises Arthritis
Spl product data elements
Usually a list of ingredients in a drug product.Medicated Balm Arthritis Pain Relieving Cream Camphor, Menthol CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL EUCALYPTUS OIL PETROLATUM CINNAMON BARK OIL PARAFFIN CERESIN PEPPERMINT 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.Packaging image description
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop using and consult with doctor if: Condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days allergic to salicylates or aspirin
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: On wound or damaged skin Otherwise than as directed
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 accidental ingestion, contact a doctor or poision control center immediately
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, mouth, or mucous membranes Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnant or lactating women Consult a doctor before using
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