FDA.reportPublic FDA data

Valtrúm US Soothing Topical Analgesic Ointment

Manufacturer
Laboratorios Quantium LLC
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:30:09

Label at a glance#

ProductValtrum US Soothing Topical Analgesic
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure14 sections

Storage and handling

Flammable: Keep away from heat and flame

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Camphor 3%                         

Menthol 3%                           

OTC - PURPOSE SECTION

PurposePain Relieving

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS

For external use only


OTC - WHEN USING SECTION

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 SECTION

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 SECTION

Flammable: Keep away from heat and flame

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

SPL UNCLASSIFIED SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValtrumValtrum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045376camphor 3 % / menthol 3 % Topical OintmentPSN3
1092556Valtrum 3 % / 3 % Topical OintmentPSN3
1092556camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Ointment [Valtrum]SBD3
1045376camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical OintmentSCD3
1045376camphor 3 % / menthol 3 % Topical OintmentSY3
1092556Valtrum (camphor 3 % / menthol 3 % ) Topical OintmentSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75849-100-002022-01-28C16284748780-1ab0e2407-29fe-f274-e053-dbdaa90a6471Valtrúm US Soothing Topical Analgesic Ointment
75849-100-002020-09-24C16284748780-1ab0e2407-29fe-f274-e053-dbdaa90a6471Valtrúm US Soothing Topical Analgesic Ointment
75849-100-002020-07-22C16284748780-1ab0e2407-29fe-f274-e053-dbdaa90a6471Valtrúm US Soothing Topical Analgesic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-100-00Valtrum US Soothing Topical Analgesic90 g in 1 BOTTLE, WITH APPLICATOROINTMENT903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-100VALTRUM US SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL) OINTMENT [LABORATORIOS QUANTIUM LLC]3Legacy NDC, 1 package rows20200925_17ff1a89-e407-470c-b013-8d00c2222002.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZW1
CAT'S CLAWINACTIVE INGREDIENT9060PRM18Q1
GLUCOSAMINEINACTIVE INGREDIENTN08U5BOQ1K1
HARPAGOPHYTUM PROCUMBENS ROOTINACTIVE INGREDIENT1OYM338E891
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75849-10075849-100-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ARNICA MONTANAO80TY208ZWIACT
CAT'S CLAW9060PRM18QIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
GLUCOSAMINEN08U5BOQ1KIACT
METHYL SALICYLATELAV5U5022YIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 89 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
b000471b-61e4-7b0b-e053-2a95a90af9cb17ff1a89-e407-470c-b013-8d00c22220022020-09-23WarningsExact identifier
spl id: b000471b-61e4-7b0b-e053-2a95a90af9cb
spl set id: 17ff1a89-e407-470c-b013-8d00c2222002

Reported adverse events (FAERS/openFDA)#

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