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| Product NDC Code | 76348-998 | ||||
|---|---|---|---|---|---|
| Drug Name | Steel city greats menthol revive |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | RENU LABORATORIES, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 5%
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.Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol, alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool), Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG), Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, 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.For temporary relief of minor aches and pains associated with arthritis simple backache muscle strains sprains bruises
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.STEEL CITY GREATS MENTHOL REVIVE Menthol CANNABICHROMENE PEG-100 STEARATE WATER GLYCERYL MONOSTEARATE OLIVE OIL WITCH HAZEL SHEA BUTTER LAURETH-7 PEPPERMINT OIL C13-14 ISOPARAFFIN WHITE WAX STEARIC ACID COCONUT OIL MANGIFERA INDICA SEED BUTTER CANNABIS SATIVA SEED OIL CANNABIGEROL CORN OIL CANNABIDIOL MENTHOL MENTHOL CETEARYL GLUCOSIDE PHENOXYETHANOL MAGNESIUM SULFATE, UNSPECIFIED POLYACRYLAMIDE (10000 MW) CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN
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.JAR LABEL FOR PRODUCT JAR 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.Indications and Usage This is a clone of another product. Only slight changes to wording have happened. Nothing major. Dosage and Administration - Directions were simplified.
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.Sugarloaf Organics Drums, PA 18222 P: 570.866.5882 www.sugarloaforganic.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 or if 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.Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use with heating pads or other heating devices.
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
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