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Dirt pain relieving gel - Medication Information

Product NDC Code 83067-463
Drug Name

Dirt pain relieving gel

Type Brand
Active Ingredients
Menthol 40 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 415974
Application Number M017
Labeler Name PURIVITAE, LLC
Packages
Package NDC Code Description
83067-463-00 88 ml in 1 bottle (83067-463-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients: Menthol 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 over 12 years of age: ask a doctor Children 12 years or younger: apply generously to affected areas rub into affected area until absorbed into the skin repeat as necessary, but no more than 4 times daily

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Activated Charcoal, Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, llex Paraguariensis (Verba Mate') Extract, Melaleuca Alternilolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.

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 arthritis, simple back aches, strains, bruises, and 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.
DIRT Pain Relieving Gel MENTHOL ACTIVATED CHARCOAL ALOE VERA LEAF WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CALENDULA OFFICINALIS FLOWER ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERIN ILEX PARAGUARIENSIS LEAF TEA TREE OIL DIMETHYL SULFONE PHENOXYETHANOL POLYSORBATE 20 PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE 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 Labeliing: Label

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

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 use on damaged or broken 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 swallowed, 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 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.
When using this product avoid contact with the eyes or mucous membranes do not bandage tightly

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, 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 Do not use on damaged or broken skin When using this product avoid contact with the eyes or mucous membranes do not bandage tightly 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away If pregnant or breast-feeding, ask a health professional before use

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