FDA.reportPublic FDA data

NitroVal Blue cream

Manufacturer
PLUM VALLEYPHARMA LLC
Effective date
2022-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:56

Label at a glance#

ProductNitroVal Blue
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients:

Menthol USP 3.7%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses Temporary relief from minor aches and pains of sore muscles & Joints associated with arthritis, simple backache, strains, bruises & sprains.

WARNINGS SECTION

Warnings

For external use only. Keep away from excessive hear or flame.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes or mucous membranes not apply to wounds or damaged skin.
  • Do not use with other ointments, creams, sprays, or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandaged not use with heating pad or device
  • Wash hands after use with cool water

OTC - STOP USE SECTION

Stop use and ask a doctor if

Condition worsens, or if symptoms persist for more than 7 days, or clear up and return.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings
If pregnant or breast-feeding: Ask a health professional before use.
Keep out of reach of children: If accidentally ingested, get medical
help or contact Poison Control Center immediately.
Other: Store in a cool dry place. Close cap tightly.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Adults and children 12 years of age and older:
    Apply and massage onto affected areas. Repeat as needed no more
    than 4 times daily. Wash hands after use with cool water.
  • Children under 12 years of age: Consult physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana
Flower Extract, Carbomer, Dimethyl Sulfone (MSM), EDTA, FDC Blue
#1, ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamin B6),
Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutyl parabens,
Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate,
Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured For:
Plum Valley Pharma, LLC
Dear born, MI 48120 USA
Questions and Information please call
Toll Free: 866-248-1553

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82226-160-85                 For Topical Use Only

NitroValBLUE

Pain Relief Cream

Plum
Valley Pharma

Net Wt. 3 oz. (85g) Topical Analgesic

Made in USA

Manufactured For:
Plum Valley Pharma, LLC
Dear born, MI 48120 USA
Questions and Information please call
Toll Free: 866-248-1553

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1655936menthol 3.7 % Topical CreamPSN1
1655936menthol 37 MG/ML Topical CreamSCD1
1655936menthol 3.7 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82226-160-852024-01-30C16284748780-11030e365-623d-111a-e063-dadaa90a10e2NitroVal Blue cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82226-160-85NitroVal Blue85 g in 1 JARCREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82226-160NITROVAL BLUE (MENTHOL) CREAM [PLUM VALLEYPHARMA LLC]1Legacy NDC, 1 package rows20220624_bf40f3dd-5612-40e4-9fbf-8d306f75cedb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82226-160-85GM - Gram82226-160869905a1-a812-4732-a198-7e33073ae5da12022-07-06

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82226-16082226-160-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOLY050HYR4XAIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
TROLAMINE9O3K93S3TKIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
EDETATE DISODIUM7FLD91C86KIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT

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
b58fbd42-b6eb-431f-9412-1773841d80c6bf40f3dd-5612-40e4-9fbf-8d306f75cedb2022-06-21WarningsExact identifier
spl id: b58fbd42-b6eb-431f-9412-1773841d80c6
spl set id: bf40f3dd-5612-40e4-9fbf-8d306f75cedb

Reported adverse events (FAERS/openFDA)#

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