Valtrum Soothing Topical Analgesic
FDA Label NDC 75849-300

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 Soothing Topical Analgesic (NDC 75849-300). 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, do not use, flammable:, 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 2,5%

Menthol 2,5%

Methyl Salicilate 10%

Purpose

Pain Relieving

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with •Rheumatism •Muscle strain •Sprains •Bruises •Neck and Shoulder Stiffness

Warnings

  • For External use only

When Using This Product

  • Use only as directed.
  • Do not get into eyes or on mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Do Not Use

  • in children under 8 years of age.
  • if pregnant or nursing.
  • with heating pad or apply external heat.

Flammable:

  • Keep away from heat and flame.

Stop Use And Ask Doctor If

  • Skin redness or excessive irritation of the skin occurs
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within  a few days.

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply directly to the affected area. Do not rub or massage. The skin will absorb quickly. Apply every 6 hours. Do not use more than 4 times daily

Inactive Ingredients:

Alcohol, Arnica Plant Extract, Carbopol, Cat's Claw Plant Extract, Devil's Claw Plant Extract, Chuchuhuasi Plant Extract, Glucosamine, Trietanolamina, water.

Other Information:

For your protection, this bottle has an imprinted seal around the neck. Do not use if tamper evident seal is missing, broken or destroyed.

Package Labeling:

Label (Label)

Label (Label)

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