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| Product NDC Code | 42346-520 | ||||
|---|---|---|---|---|---|
| Drug Name | Frankincense and myrrh intensive foot therapy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 2045268 | ||||
| Application Number | M017 | ||||
| Labeler Name | Wise Consumer Products | ||||
| 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 ingredient Menthol 1.3%
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 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Lanolin, Cetearyl Alcohol, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearyl, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 60, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol, Xanthan Gum, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Medica Limonum (Lemon) Peel 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.Uses For the temporary relief of minor aches and pains.
Purpose
Information about the drug product’s indications for use.Purpose Menthol 1.3%................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Frankincense and Myrrh Intensive Foot Therapy menthol WATER MEDIUM-CHAIN TRIGLYCERIDES GERANIUM OIL, ALGERIAN TYPE NUTMEG OIL MENTHOL MENTHOL STEARYL ALCOHOL POLYSORBATE 60 EUCALYPTUS OIL PHENOXYETHANOL MYRRH OIL LANOLIN CETOSTEARYL ALCOHOL GLYCERIN COCOA BUTTER GLYCERYL MONOSTEARATE COCONUT OIL BERGAMOT OIL CETYL ALCOHOL ROSEMARY OIL XANTHAN GUM CINNAMON OIL FRANKINCENSE OIL LEMON OIL, COLD PRESSED SHEA BUTTER
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.Frankincense & Myrrh Intensive Foot Therapy Lotion Safe for Diabetics Fast Pain Relief Hydrating Repair Menthol 1.3% Temporary Topical Analgesic Net Wt. 3 oz (85g) 2 1
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 wounds or damaged skin over large areas of the body
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-877-917-9674 Mon-Fri, 9 a.m. - 5 p.m. EST www.frankincensemyrrh.com
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 irritation occurs 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 do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool, dry place tamper resistant: do not use if seal under tube cap is broken or missing
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 Do not use on wounds or damaged skin over large areas of the body When using this product avoid contact with the eyes do not bandage tightly Stop use and ask a doctor if condition worsens irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use. Keep out of the reach of children. If swallowed, 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