FDA.reportPublic FDA data

Natures Oil 16% Menthol

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:48

Label at a glance#

ProductNatures Oil 16% Menthol
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

relieves minor pain of muscles and joins associated with: arthritis simple backache strains bruises sprains

Dosage and administration

- shake well adults and children 12 years of age and older: spray product on area not more than 1 to 3 times daily children under 12 years of age ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • relieves minor pain of muscles and joins associated with:
    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains

Warnings

WARNINGS SECTION

For external use only

Flammable:

  • Do not use while smoking or near heat or flame

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged, broken or irritated skin. - Do not allow contact with eyes or mucous membranes.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes
  • do not bandage tightly
  • do not use with a heating pad
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

Keep out of reach of children and pets.

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

- shake well

  • adults and children 12 years of age and older:
    • spray product on area not more than 1 to 3 times daily
  • children under 12 years of age
    • ask a doctor

Other information

OTHER SAFETY INFORMATION

  • May cause staining. Use with caution when spraying near fabric and unprotected surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Propylene Glycol, SDA 40-2 Alcohol, Water.

Principal Display Panel - 118 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURE'S OIL

16% Menthol
Spray

Net Wt 4 oz (113g)

Manufactured For:

Nature's Oil

1800 Miller Parkway
Streetsboro, Ohio 44241

www.NaturesOil.com

Principal Display Panel - 118 g Can Label
Principal Display Panel - 118 g Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430458menthol 16 % Topical SprayPSN1
1430458menthol 160 MG/ML Topical SpraySCD1
1430458menthol 16 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-242-04Natures Oil 16% Menthol118 g in 1 CANSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-242NATURES OIL 16% MENTHOL (MENTHOL, UNSPECIFIED FORM) SPRAY [NATURAL ESSENTIALS, INC.]1Current NDC, 1 package rows20240221_2fbe23b7-23a3-4f0b-bc08-0205256f5d68.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-24266902-242-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
Natures Oil 16% MentholMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.2fbe23b7-23a3-4f0b-bc08-0205256f5d682024-02-14WarningsExact identifier
ndc (package): 66902-242-04
ndc (product): 66902-242
ndc11 (package): 66902024204
spl id: ba18f02b-6c9a-4cb6-b512-27960cbdd2db
spl set id: 2fbe23b7-23a3-4f0b-bc08-0205256f5d68

Reported adverse events (FAERS/openFDA)#

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