FDA.reportPublic FDA data

CarvaNum

Manufacturer
Innovus Pharmaceuticals, Inc.
Effective date
2021-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:12

Label at a glance#

ProductCarvaNum
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

For the temporary relief minor aches and pains of muscles and joints associated with: simple backaches arthritis strains bruises sprains

Dosage and administration

Use only as directed Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5% 

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged, broken or irritated skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

unintended effects occur

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Use only as directed

  • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

Store at RT. Do not purchase if outer seal is broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat. (SD Alcohol 40-B), Allium Sativum (Garlic) Bulb Extract/Propylene glycol, Beeswax, Cetyl Alcohol, Ethylhexyl Palmitate, Glyceryl Stearate SE, Glyceryl Stearate/PEG-100 Stearate, Propylene Glycol, Poloxamer 407, Phenoxyethanol/Caprylyl Glycol/Ethylhexylglycerin/Hexylene Glycol, Potassium Hydroxide, Purified Water, Sodium Bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CarvaNum CartonCarvaNum Carton

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-30157483-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
GARLICV1V998DC17IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
POLOXAMER 407TUF2IVW3M2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT

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
a2dede7e-71d9-4d8e-9041-77bca844c9c5768e2220-5bc3-4181-a575-ad5fa75b94de2023-01-13WarningsExact identifier
spl set id: 768e2220-5bc3-4181-a575-ad5fa75b94de

Reported adverse events (FAERS/openFDA)#

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