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Top medicated oil - Medication Information

Product NDC Code 82198-0009
Drug Name

Top medicated oil

Type Brand
Active Ingredients
Camphor (natural) 10 mg/ml
Menthol, unspecified form 16 mg/ml
Methyl salicylate 40 mg/ml
Route TOPICAL
Dosage Form OIL
Application Number M017
Labeler Name Big 5 Nutrition LLC
Packages
Package NDC Code Description
82198-0009-1 50 ml in 1 bottle (82198-0009-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Camphor 10% Menthol 16% Methyl Salicylate 40%

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 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations. • children under 12 years of age: consult your physician. • refer to the above warnings; use otherwise than as directed may be dangerous.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients • Eucalyptus oil • Lavender oil

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 Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • bruises • sprains

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Top Medicated Oil CAMPHOR, MENTHOL, METHYL SALICYLATE EUCALYPTUS OIL LAVENDER OIL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL, UNSPECIFIED FORM MENTHOL METHYL SALICYLATE SALICYLIC ACID

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.
Packaging image description

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 DISTRIBUTED BY : A&A MEDICAL SUPPLIES, INC. S. El Monte, CA 91733 USA MADE IN TAIWAN ITEM NO. HK105

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information • store at 16° to 30°C (61° to 86° F) • store in an airtight container

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 • on irritated or damaged skin • otherwise than as directed 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 • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive irritation of the skin develops • nausea, vomiting, abdominal discomfort, diarrhea, or skin rashes occurs

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