Valtrum Analgesic
FDA Label NDC 75849-312

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 Analgesic (NDC 75849-312). 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, when using this product:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 3%
Menthol 3%
Menthyl salicilate 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.

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

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.

Other Information

  • Store in a cool dry place away from direct sunlight
  • Keep lid tightly closed

Inactive Ingredients:

Arnica Montana Extract, Carbopol 940, Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate, Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine.

Package Labeling:

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Label (Label)

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