VALTRUM SOOTHING TOPICAL ANALGESIC- camphor (synthetic), menthol, methyl salicylate ointment 
Laboratorios Quantium LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Valtrum Soothing Topical Analgesic Ointment

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

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

VALTRUM SOOTHING TOPICAL ANALGESIC 
camphor (synthetic), menthol, methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75849-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)25 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
GLUCOSAMINE (UNII: N08U5BOQ1K)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75849-300-001 in 1 CARTON11/12/2015
190 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/12/2015
Labeler - Laboratorios Quantium LLC (027101451)

Revised: 9/2020
Document Id: b0617409-47b2-6e4c-e053-2995a90a721e
Set id: bf7d00d1-901a-47e4-ada7-2e647a42304c
Version: 4
Effective Time: 20200928
 
Laboratorios Quantium LLC