FDA.reportPublic FDA data

Valtrum Topical Analgesic Roll On

Manufacturer
LABORATORIOS QUANTIUM LLC | GADAL Laboratories, Inc
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:48

Label at a glance#

ProductValtrum Topical Analgesic Roll On
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, CAMPHOR (NATURAL)
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Methyl Salicylate 10%Topical Analgesic
Menthol 3%Topical Analgesic
Camphor 3%Topical Analgesic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Arnica Montana Extract, Carbopol 940,Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate,Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine

WARNINGS

WARNINGS SECTION

For the external use only.

  • Avoid contact with eyes and mucous membranes.
  • Do not use otherwise than as directed

Caution:Discontinue use if excessive irritation of the skin develops.

When using this product use as directed.

OTC - WHEN USING SECTION

  • Do not bandage tightly.
  • Do not apply to wounds or damaged skin.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Conditions worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years of age and older: Spray a thin layer over the affected area not more than 3 to 4 times daily.
Children under 18 years of age: Consult a doctor.

PURPOSE

OTC - PURPOSE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Santo Remedio Aerobic Sports

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUANTIUMMED DISTRIBUTORS, INC
MIAMI - FL, 33172

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2123377camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical GelPSN3
2123377camphor 0.03 MG/MG / menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Topical GelSCD3
2123377camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75849-301-032023-11-28C16284748780-1ba0f9c33-3b46-a910-e053-dadaa90a0b8528167e2a-9afb-44e7-90c7-9577df9504b6
75849-301-032023-01-30C16284748780-1ba0f9c33-3b46-a910-e053-dadaa90a0b8528167e2a-9afb-44e7-90c7-9577df9504b6
75849-301-032021-08-25C16284748780-1ba0f9c33-3b46-a910-e053-dadaa90a0b8528167e2a-9afb-44e7-90c7-9577df9504b6
75849-301-032021-01-29C16284748780-1ba0f9c33-3b46-a910-e053-dadaa90a0b8528167e2a-9afb-44e7-90c7-9577df9504b6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-301-03Valtrum Topical Analgesic Roll On90 g in 1 TUBE, WITH APPLICATORGEL903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-301VALTRUM TOPICAL ANALGESIC ROLL ON (SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)) GEL [LABORATORIOS QUANTIUM LLC]3Current NDC, Legacy NDC, 1 package rows20231129_28167e2a-9afb-44e7-90c7-9577df9504b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75849-30175849-301-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ARNICA MONTANA WHOLEO80TY208ZWIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CAT'S CLAW9060PRM18QIACT
MAYTENUS MACROCARPA BARKK50SD0PDVRIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-40 SORBITAN DIISOSTEARATEJL4CCU7I1GIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum Topical Analgesic Roll OnSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC28167e2a-9afb-44e7-90c7-9577df9504b62023-11-09WarningsExact identifier
ndc (package): 75849-301-03
ndc (product): 75849-301
ndc11 (package): 75849030103
spl id: e0089b62-e19a-4ab7-a2f0-a8e9a70ff2e8
spl set id: 28167e2a-9afb-44e7-90c7-9577df9504b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.