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Debbies down and dirty deep tissue joint and muscle - Medication Information

Product NDC Code 71523-833
Drug Name

Debbies down and dirty deep tissue joint and muscle

Type Brand
Active Ingredients
Menthol 100 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 253020
Application Number M017
Labeler Name DD&D Manufacturing Co., Ltd
Packages
Package NDC Code Description
71523-833-01 1 bottle in 1 box (71523-833-01) / 118 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Menthol 10% 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 Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, 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 For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

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.
Debbies Down and Dirty Deep Tissue Joint and Muscle MENTHOL HELIANTHUS ANNUUS FLOWERING TOP METHYL SALICYLATE DIMETHYL SULFONE PEG-100 STEARATE PHENOXYETHANOL WILLOW BARK TROLAMINE XANTHAN GUM WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE BROMELAINS BUTYLENE GLYCOL CARBOXYPOLYMETHYLENE CETYL ALCOHOL ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERYL MONOSTEARATE GLYCYRRHIZA GLABRA MENTHOL MENTHOL

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.
Package labeling: Label3

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

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 physician before use if you have redness over the affected area.

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.
Do not apply to wounds or damaged 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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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 physician if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs.

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. do not bandage.

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 Do not apply to wounds or damaged skin. Ask a physician before use if you have redness over the affected area. When using this product avoid contact with the eyes. do not bandage. Stop use and ask a physician if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs. Keep out of reach of children. In case of accidental ingestion, 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