FDA.reportPublic FDA data

Valtrum ® us IMMEDIATE ACTION TOPICAL ANALGESIC CREAM

Manufacturer
LABORATORIOS QUANTIUM LLC
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:16

Label at a glance#

ProductValtrum IMMEDIATE ACTION TOPICAL ANALGESIC
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%
Menthol 3%
Methyl salicylate 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: • Do not bandage tightly • Do not apply to wounds or damaged skin.

Stop use and ask a doctor if: • Conditions worsens • Symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health professional before use.

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.

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Cetyl Stearyl Alcohol, DMDM Hydantoin, Glucosamine Sulfate, Mineral Oil, PEG-20 Cetyl/Stearyl Ether, Polysorbate 20, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Analgesic-897Analgesic-897

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2673206camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical CreamPSN1
2673206camphor 30 MG/ML / menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD1
2673206camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-897-03Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC90 g in 1 TUBECREAM901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-897VALTRUM IMMEDIATE ACTION TOPICAL ANALGESIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [LABORATORIOS QUANTIUM LLC]1Current NDC, 1 package rows20240116_c4efa317-8dd1-49e1-b7ca-9df2147edd3e.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
75849-89775849-897-03

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DMDM HYDANTOINBYR0546TOWIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

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 IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
ndc (package): 75849-897-03
ndc (product): 75849-897
ndc11 (package): 75849089703
spl id: d492a160-8eea-49bf-a0fa-b918c9aec441
spl set id: c4efa317-8dd1-49e1-b7ca-9df2147edd3e

Reported adverse events (FAERS/openFDA)#

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