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Dynarub - Medication Information

Product NDC Code 67777-113
Drug Name

Dynarub

Type Brand
Active Ingredients
Menthol 10 g/100g
Methyl salicylate 15 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 311498
Application Number part348
Labeler Name Dynarex Corporation
Packages
Package NDC Code Description
67777-113-50 72 tube in 1 case (67777-113-50) / 85 g in 1 tube (67777-113-49)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Menthol 10% Active Ingredient Methyl Salicylate 15%

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 and older: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, 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 backache, arthritis, strains, bruises, sprains

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
DynaRub Pain Relieving Cream GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE METHYLPARABEN PHENOXYETHANOL SODIUM HYDROXIDE STEARIC ACID EDETATE DISODIUM ANHYDROUS WATER MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID ALLANTOIN CARBOXYPOLYMETHYLENE DIMETHICONE CETYL ALCOHOL TITANIUM DIOXIDE ALPHA-TOCOPHEROL ACETATE XANTHAN GUM POTASSIUM CETYL PHOSPHATE PROPYLPARABEN POLYSORBATE 20

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.
Label 1135 DynRub

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 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.
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 symptoms last 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 eyes do not bandage tightly

Storage and handling

Information about safe storage and handling of the drug product.
Other Information store at 20°-25°C (68°-77°F).

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 wounds or damaged skin When using this product avoid contact with eyes do not bandage tightly Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days 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