FDA.reportPublic FDA data

O24 Pain Neutralizer

Manufacturer
O24 Naturals LLC | D&d Essential Oils, Llc., | Biomed Laboratories LLC
Effective date
2018-02-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:57:00

Label at a glance#

ProductO24 Pain Neutralizer
Active ingredientCAMPHOR (NATURAL)
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician

Storage and handling

store in a cool, dry place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Purpose

OTC - PURPOSE SECTION

Camphor 3.1%..........................External Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

  • apply to wounds or damaged skin
  • bandage tightly
  • use with a heating pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mucous membranes
  • use only as directed.

Stop 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTHER SAFETY INFORMATION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician

Other Information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Mentha arvensis (Peppermint Leaf) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-902-8594 or www.024zone.com

DESCRIPTION SECTION

Manufactured for

O24TM Naturals, LLC, 306 Hallmark Dr, Arlington, TX  76011


Questions?

Call TOLL-FREE: 1.866.902.8594 or visit us at: www.024zone.com

O24TM is a Registered Trademark of O24TM Naturals, LLC.

Made in U.S.A.


Active Ingredient

Camphor 3.1%

O24's Unique Process

Our unique process combines pure essential oils without the use of alcohol, glycerin, synthetics, chemical binding agents, or preservatives unlocking the full potential of all ingredients

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O24 Naturals

O24

Pain Neutralizer

Safe and Natural

Topical Pain

Relieving Spray

for minor aches and pains associated with arthritis, strains, backaches, and bruises

Spray Bottle
1 fl.oz. (30 mL)
O24painlabel
O24painlabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046527camphor 3.1 % Topical SprayPSN6
1046527camphor 31 MG/ML Topical SpraySCD6
1046527camphor 3.1 % Topical SpraySY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58265-001-302022-07-29C16284748780-1e4f33bdf-ae5b-d8a0-e053-dadaa90a6e4eDrug Facts
58265-001-942022-07-29C16284748780-1e4f33bdf-ae5b-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58265-001-30O24 Pain Neutralizer1 in 1 CARTONSPRAY16
58265-001-30O24 Pain Neutralizer30 mL in 1 BOTTLE, SPRAYSPRAY306
58265-001-94O24 Pain Neutralizer1 in 1 CARTONSPRAY16
58265-001-94O24 Pain Neutralizer9.4 mL in 1 BOTTLE, SPRAYSPRAY9.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58265-001O24 PAIN NEUTRALIZER (CAMPHOR) SPRAY [O24 NATURALS LLC]6Legacy NDC, 4 package rows20181015_0736328c-c7a9-4ca9-bc9a-322ae6e817f0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9414
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9414
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H84
LEMON OILINACTIVE INGREDIENTI9GRO824LL4
MENTHA ARVENSIS LEAF OILINACTIVE INGREDIENT1AEY1M553N4
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B4
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3934

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58265-00158265-001-30, 58265-001-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ORANGE OILAKN3KSD11BIACT
LEMON OILI9GRO824LLIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
ROSEMARY OIL8LGU7VM393IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET, CHEWABLE / ORAL3.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BPOWDER, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BSUSPENSION / ORAL1 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BLIQUID / ORAL50 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET / SUBLINGUALNAExact identifier — unii candidate
6 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
64f398dc-a763-408f-e053-2a91aa0aad200736328c-c7a9-4ca9-bc9a-322ae6e817f02018-02-11WarningsExact identifier
spl id: 64f398dc-a763-408f-e053-2a91aa0aad20
spl set id: 0736328c-c7a9-4ca9-bc9a-322ae6e817f0

Reported adverse events (FAERS/openFDA)#

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