VALTRUM SOOTHING TOPICAL ANALGESIC- camphor, menthol ointment

Valtrum Soothing Topical Analgesic by

Drug Labeling and Warnings

Valtrum Soothing Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Drogefar C.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS:

Active Ingredients                     Purpose

Camphor 3%                           Pain Relieving

Menthol 3%                            Pain Relieving

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

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.

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

SPL UNCLASSIFIED SECTION

Flammable: Keep away from heat and flame

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

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.

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    quantiumlab@gmail.com

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VALTRUM SOOTHING TOPICAL ANALGESIC 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50786-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA (UNII: O80TY208ZW)
CAT'S CLAW (UNII: 9060PRM18Q)
GLUCOSAMINE (UNII: N08U5BOQ1K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50786-003-03	90151.47 mg in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	05/06/2010

Labeler - Drogefar C.A. (855055810)

Registrant - Drogefar C.A. (855055810)

Establishment
Name	Address	ID/FEI	Business Operations
Drogefar C.A.		855055810	manufacture, label