Valtrum Us Soothing Topical Analgesic
FDA Label NDC 75849-100

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 Us Soothing Topical Analgesic (NDC 75849-100). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - do not use, storage and handling, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active Ingredients                   

Camphor 3%                         

Menthol 3%                           

Otc - Purpose

PurposePain Relieving

Indications & Usage

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

WARNINGS

For external use only


Otc - When Using

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.

Otc - Do Not Use

Do not use

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

Storage And Handling

Flammable: Keep away from heat and flame

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Dosage & Administration

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 Ingredient

Inactive Ingredients:

Alcohol, Arnica Plant Extract, Carbopol, Cat's Claw Plant Extract, Devil's Claw Plant Extract,  Chuchuhuasi Plant Extract, Glucosamine, Methyl Salicilate, Triethanolamina, Water

Other

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 Label.Principal Display Panel

POWERFUL ANALGESIC

WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL

New ROLLON

santo remedio

IMMEDIATE ACTION

VALTRUM US

Soothing Topical Analgesic Ointment

Net Wt. 3.18oz (90g)

ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN -

Temporary relief of minor pains associated with Muscle Strain, Neck and Shoulder Stiffness, Sprains and Rheumatism

MADE BY: Laboratorios Quantium, LLC.
Exclusively Distributed For USA BY:
QUANTIUMMED DISTRIBUTORS, INC.
MIAMI - FLORIDA - 33172
TELF: 305-514-9718 AND 786-2508995
email: QUANTIUMMED GMAIL.COM
QUANTIUMLAB GMAIL.COM

Valtrum (Valtrum)

Valtrum (Valtrum)

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