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Product NDC Code | 75849-897 | ||||||
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Drug Name | Valtrum immediate action topical analgesic |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 2673206 | ||||||
Application Number | M017 | ||||||
Labeler Name | LABORATORIOS QUANTIUM LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Camphor 3% Menthol 3% Methyl salicylate 10%
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 18 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 18 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Cetyl Stearyl Alcohol, DMDM Hydantoin, Glucosamine Sulfate, Mineral Oil, PEG-20 Cetyl/Stearyl Ether, Polysorbate 20, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate.
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
Spl product data elements
Usually a list of ingredients in a drug product.Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC Camphor, Menthol, Methyl salicylate CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL, UNSPECIFIED FORM MENTHOL METHYL SALICYLATE SALICYLIC ACID CETOSTEARYL ALCOHOL DMDM HYDANTOIN GLUCOSAMINE SULFATE MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER POLYSORBATE 20 WATER SODIUM HYDROXIDE STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE, D-
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 Analgesic-897
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
POWERFUL ANALGESIC NEW CREAM santo remedio [email protected] www.valtrum-santoremedio.com
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 in a cool dry place away from direct sunlight • Keep lid tightly closed
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 • Avoid contact with eyes and mucous membranes • Do not use otherwise than as directed. Caution: Discontinue use if excessive irritation of the skin develops. When using this product: • Do not bandage tightly • Do not apply to wounds or damaged skin. Stop use and ask a doctor if: • Conditions worsens • Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding , ask a health professional before use. 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