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Product NDC Code | 73769-451 | ||||||
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Drug Name | Mystic essentials zen pain relief rub |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 2689128 | ||||||
Application Number | M017 | ||||||
Labeler Name | NATURE'S FUSIONS, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Camphor 0.5% - Topical Analgesic (pain relief) Menthol 3.00% - Topical Analgesic (pain relief)
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 and older: Apply to the affected area no more than 3 to 4 times daily. Children under the age of 12: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Basil Linalool Oil, Eucalyptus Oil, Evening Primrose Oil, Frankincense Oil, Fractionated Coconut Oil, Ginger Root Oil, Lavender Oil, Lemongrass Oil, Peppermint Oil, Rosemary + 1,8 Cineole Oil, Wintergreen 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.Directions Adults and children 12 years and older: Apply to the affected area no more than 3 to 4 times daily. Children under the age of 12: Ask a doctor.
Purpose
Information about the drug product’s indications for use.USES For the temporary relief of minor aches and pain associated with *backache *arthritis *muscle strains *strains *bruises
Spl product data elements
Usually a list of ingredients in a drug product.Mystic Essentials Zen Pain Relief Rub Camphor, Menthol ROSEMARY OIL LAVENDER OIL METHYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES PEPPERMINT OIL EUCALYPTUS OIL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL GINGER OIL EAST INDIAN LEMONGRASS OIL BASIL OIL INDIAN FRANKINCENSE EVENING PRIMROSE 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.10ml Carton 1 10ml Carton 2 10ml Carton 3 30ml Carton 1 30ml Carton 2 30ml Carton 3
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 our of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Keep container tightly closed Store at room temperature (68°-77° F)
Questions? Call (800) 352-7032
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 Do not use on wounds - damaged, broken, or irritated skin Stop use and ask doctor if condition worsens * irritation develops *redness is present *symptoms persist for more than 7 days or clear up and occur again within a few days ______________________________ When using this product Use only as directed Avoid contact with eyes or mucous membranes Do not bandage tightly or use with a heating pad. ______________________________ If Pregnant or breast feeding , ask a health professional before use.
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