Valtrum Topical Analgesic Cream
FDA Label NDC 75849-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Quantium Llc for the product Valtrum Topical Analgesic (NDC 75849-031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Camphor 3%
Menthol 3%
Methyl salicylate 10%
Purpose
Topical analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with • Simple Backache • Arthritis • Strains • Bruises • Sprains
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.
Otc - Keep Out Of Reach Of Children
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.
Directions
Adult 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.
Other Information
• Store in a cool dry place away from direct sunlight • Keep lid tightly closed
Inactive Ingredients:
Arnica Montana Extract, Cat's Claw Extract, Cetyl Stearyl Alcohol, Chuchuhuasi Extract, Devil's Claw Extract, DMDM Hydantoin, Ether, Glucosamine Sulfate, Mineral Oil, PEG-20 Cetyl/Stearyl Ether, Polysorbate 20, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate.
Packaging
Valtrum Topical Analgesic (75849031 1)
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