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| Product NDC Code | 72342-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relieving |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LINIMENT | ||||
| RxCUI drug identifier | 435780 | ||||
| Application Number | M017 | ||||
| Labeler Name | J.R. Watkins, LLC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients CAMPHOR 3.5%
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 Lift silver tab to open Use only as directed Adults and children 2 years and older: Pat onto affected area not more than 3-4 times daily. Children under 2 years of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients capsicum oleoresin (chili pepper extract), potassium carbonate, potassium cocoate, SD alcohol 40B, spruce oil, 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 for 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 EXTERNAL ANALGESIC
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relieving CAMPHOR (NATURAL) WATER ALCOHOL PICEA MARIANA LEAF OIL POTASSIUM COCOATE CAPSICUM OLEORESIN POTASSIUM CARBONATE CAMPHOR (NATURAL) CAMPHOR (NATURAL)
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.PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label ESTD 1868 J.R. WATKINS REMEDIES FOR BODY ® PAIN RELIEVING LINIMENT EXTERNAL ANALGESIC WITH CAMPHOR SIMPLY RUB ONTO SKIN FOR RELIEF RELIEF FOR SIMPLE BACKACHE, ARTHRITIS, SPRAINS & MUSCLE STRAINS NOW DYE FREE 11 FL OZ (325 mL) FL02317NR4 PRINCIPAL DISPLAY PANEL - 325 mL Bottle 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
DISTRIBUTED BY J.R. WATKINS, LLC Oakland, CA 94612
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 with a heading pad
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-888-384-1945 Do not use if tamper evident seal is not intact
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 persist for more than 7 days symptoms 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, nostrils and mouth do not bandage tightly
Storage and handling
Information about safe storage and handling of the drug product.Other information do not use if tamper evident seal is not intact close container tightly and store at room temperature away from heat (dry, well-ventilated premises at 59-77°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. When using this product avoid contact with eyes, nostrils and mouth do not bandage tightly Flammable: Keep away from fire, sparks and heated surfaces Do not use on wounds or damaged skin with a heading pad 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 Keep out of reach of children. 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