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Topical analgesic - Medication Information

Product NDC Code 80986-101
Drug Name

Topical analgesic

Type Brand
Active Ingredients
Menthol 1.4 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 2391332
Application Number part348
Labeler Name Youngevity International Inc.
Packages
Package NDC Code Description
80986-101-01 59 g in 1 jar (80986-101-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Menthol 1.4%, Purpose: Topical Analgesic

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 2 years of age or older, apply to affected area no more than 3 to 4 times a day. children under 2 years of age, consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Carbomer, celadrin (cetyl myristoleate, cetyl myristate, cetyl palmitaoleate, cetyl oleate, cetyl laurate), cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl monostearate, myristyl alcohol, olive oil, peppermint oil, phenoxyethanol, polysorbate 20, propylene glycol, stearic acid, triethanolamine, water

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 on minor aches and pains of sore muscles and joints associated with: Backaches arthritis strains bruises sprains

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Topical Analgesic Menthol CETYL TALLOWATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE STEARIC ACID OLIVE OIL PEPPERMINT OIL POLYSORBATE 20 ETHYLHEXYLGLYCERIN PHENOXYETHANOL TROLAMINE MENTHOL MENTHOL GLYCERYL STEARATE SE CETYL ALCOHOL WATER GLYCERIN PROPYLENE GLYCOL Cream

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.
PDP Ultimate CM Cream Muscle and Joint Support 2 fl oz CM Cream Label

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.
Stop use and ask a doctor Stop use and ask a doctor if condition worsens symptoms persists for more than 7 day or clears up and occurs again within a few days

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.

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 When using this product: Keep out of eyes, ears, and mouth In case of contact with eyes, rinse eyes thoroughly with water Do not apply to wounds or damaged skin Do not bandage tightly

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store in a cool, dry place

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.

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