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| Product NDC Code | 76348-681 | ||||
|---|---|---|---|---|---|
| Drug Name | Op6 menthol warming pain cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part348 | ||||
| Labeler Name | Renu Laboratories, 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.Menthol 5 percent
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 generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract and proprietary terpene blend (Myrcene, b-Caryophyllene, d-Limonene, Humulene, Terpinolene, a-Pinene, Linalool, b-Pinene, Valencene, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid
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 temporary relief of minor aches and pains asssociated with arthritis simple backache muscle strains sprains bruises SIMPLE DATE CHANGE Nothing considered as major
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.op6 Menthol Warming Pain Cream Menthol TABASCO PEPPER .BETA.-PINENE HUMULENE TERPINOLENE LINALOOL, (+)- VALENCENE MENTHOL MENTHOL CANNABIDIOL WATER POLYETHYLENE GLYCOL 4500 CORN OIL MANGIFERA INDICA SEED BUTTER PEPPERMINT OIL PEPPERMINT PHENOXYETHANOL POLYACRYLAMIDE (10000 MW) GLYCERYL MONOSTEARATE CETEARYL GLUCOSIDE COCONUT OIL WHITE WAX SHEA BUTTER C13-14 ISOPARAFFIN CANNABIS SATIVA SEED OIL CETOSTEARYL ALCOHOL OLIVE OIL STEARIC ACID GRAPEFRUIT OIL MAGNESIUM CHLORIDE MAGNESIUM SULFATE, UNSPECIFIED LAURETH-7 WITCH HAZEL MYRCENE LIMONENE, (+)- CARYOPHYLLENE .ALPHA.-PINENE
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.PRODUCT LABEL AND BOX ART Warming Box Warming Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.SIMPLE DATE CHANGE Nothing considered as major
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 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 631 697 0296 ACD HEALTH AND WELLNESS LLC ACDHEALTH.COM
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 When using this product do not bandage tightly avoid contact with eye do not apply to wounds or damaged skin Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed get medical help or contact Poison Control Center right away Keep out of 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