FDA.reportPublic FDA data

Valtrum Topical Analgesic Gel

Manufacturer
Laboratorios Quantium LLC | GADAL Laboratories, Inc
Effective date
2021-08-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:59

Label at a glance#

ProductValtrum Analgesic
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, MENTHYL SALICYLATE, (+/-)-
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with • Simple Backache • Arthritis • Strains • Bruises • Sprains

Dosage and administration

Adults and Children 18 years of age and older:  Apply to affected area not more than 3 to 4 times daily.  Children under 18 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%
Menthol 3%
Menthyl salicilate 10%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

• Simple Backache • Arthritis • Strains • Bruises • Sprains

Warnings

WARNINGS SECTION

For 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:

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 18 years of age and older: Apply to affected area not more than 3 to 4 times daily.  Children under 18 years of age: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store in a cool dry place away from direct sunlight
  • Keep lid tightly closed

Inactive Ingredients:

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.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75849-312-032023-01-30C16284748780-1f386c649-d7d1-0266-e053-dadaa90a7c1aValtrum Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-312-03Valtrum Analgesic90 g in 1 TUBEGEL903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-312VALTRUM ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, MENTHYL SALICYLATE) GEL [LABORATORIOS QUANTIUM LLC]3Legacy NDC, 1 package rows20210820_c72e768c-d1ee-ba0b-e053-2a95a90a5f99.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75849-31275849-312-03

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
CAT'S CLAW9060PRM18QIACT
MAYTENUS KRUKOVII BARKK50SD0PDVRIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-40 CASTOR OIL4ERD2076EFIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
MENTHYL SALICYLATE, (+/-)-43XOA705ZDACTIB
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT

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
c9ed6773-b657-720c-e053-2a95a90ae2b1c72e768c-d1ee-ba0b-e053-2a95a90a5f992021-08-19WarningsExact identifier
spl id: c9ed6773-b657-720c-e053-2a95a90ae2b1
spl set id: c72e768c-d1ee-ba0b-e053-2a95a90a5f99

Reported adverse events (FAERS/openFDA)#

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