Otc - Active Ingredient
DRUG FACTS:
Active Ingredients Purpose
Camphor 3% Pain Relieving
Menthol 3% Pain Relieving
Valtrum Soothing Topical Analgesic
FDA Label NDC 50786-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drogefar C.a. for the product Valtrum Soothing Topical Analgesic (NDC 50786-003). 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, otc - when using, otc - do not use, other, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Otc - When Using
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.
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
Other
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, Cat's Claw Plant Extract, Chuchuhuasi Plant Extract, Devil's Claw Plant Extract, Eucalyptus Plant Extract, Frailejon Plant Extract, Glucosamine, Mango Leaf Extract, Rosemary Plant Extract, Rue Plant Extract, Sarsaparila Plant Extract, Water
Information For Patients
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
Soothing Topical Analgesic Ointment
Net Wt. 3.18oz (90g)
ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN -
Distributed by Laboratorios Quantium LLC
Miami, FL 33012 [email protected]
Manufactured by: Drogefar, C.A. Caracas,
Venezuela, Zp 1050
Lot:
Exp:
Made In the Bolivian Republic of Venezuela
Temporary relief of minor pains associated with Muscle Strain, Neck and Shoulder Stiffness, Sprains and Rheumatism
Ointmentlabel (Valtrum Ointment Outer Label)
* Please review the disclaimer below.
