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Product NDC Code | 83696-603 | ||||
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Drug Name | Medterra pain relief 1000mg hemp menthol cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M017 | ||||
Labeler Name | Respect Manufacturing Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 4%
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: Apply cream to affected areas daily as needed. Consult with a physician for optimal usage.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Argania Spinosa Kernel Oil, Arnica Montana Flower Extract, Bentonite, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Helianthus Annus (Sunflower) Extract, Hemp Extract, Mentha Piperita (Peppermint) Oil, Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Water (Aqua), Xanthan Gum.
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: Temporary relief of minor aches and pains of sore muscles & joints associated with: Arthritis · Backache · Strains · Sprains
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Medterra Pain Relief 1000mg Hemp Menthol Cream Menthol TOCOPHEROL ALOE VERA LEAF WATER GLYCERYL STEARATE SE SUNFLOWER SEED RICE BRAN XANTHAN GUM GLYCERIN JOJOBA OIL SHEA BUTTER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CITRIC ACID MONOHYDRATE CAPRYLYL GLYCOL ARGAN OIL PHENOXYETHANOL ROSEMARY CETOSTEARYL ALCOHOL COCONUT OIL ARNICA MONTANA FLOWER ETHYLHEXYLGLYCERIN HEMP PEPPERMINT OIL PEPPERMINT BENTONITE MEDIUM-CHAIN TRIGLYCERIDES
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.medterra Pain Relief 1000MG Hemp per container + MENTHOL Cream Hemp Topical · 1.7 fl. oz. (50.3mL) Our Pain Relief cream combines menthol, hemp, and powerful botanical ingredients to deliver fast relief for arthritis & joint pain. Trusted transparency, always. Scan code for detailed lab results. Package Label
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.Ask a doctor before use if you have: Sensitive skin
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: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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? (800) 971-1288 | [email protected] medterracbd.com | @medterracbd.com Manufactured for Medterra CBD, LLC. 18500 Von Karman Ave., Suite 100, Irvine, CA 92612 *Third-party testing ensures non-detectable levels of THC (defined as less than .01%) THIS MEDTERRA CBD PRODUCT HAS BEEN INDEPENDENTLY CERTIFIED BY THE U.S. HEMP AUTHORITY™ TO ENSURE THE HIGHEST QUALITY STANDARDS ARE MET THROUGH EACH STEP OF CULTIVATION AND MANUFACTURING.
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: Conditions worsens, or if symptoms persist for more than 7 days, or clear up and recur.
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 or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: Ask a health professional before use.
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.
Flammable: Keep away from excessive heat or open flame.
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