FDA.reportPublic FDA data

O24

Manufacturer
Revive Bioscience, Inc. | Sigan Industries
Effective date
2012-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:30:50

Label at a glance#

ProductO24 Essential Oil Pain Relieving
Active ingredientCAMPHOR (SYNTHETIC)
Label structure14 sections

Storage and handling

store in a cool, dry place

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

camphor 3.1%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes

OTC - DO NOT USE SECTION

Do not

  • apply to wounds or damaged skin
  • bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician

STORAGE AND HANDLING SECTION

store in a cool, dry place

INACTIVE INGREDIENT SECTION

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

OTC - QUESTIONS SECTION

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O24 towelette labelO24 towelette label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243307camphor 3.1 % Medicated PadPSN3
1243312O24 Pain Neutralizer 3.1 % Medicated PadPSN3
1243312camphor 31 MG/ML Medicated Pad [O24 Pain Neutralizer]SBD3
1243307camphor 31 MG/ML Medicated PadSCD3
1243307camphor 3.1 % Medicated PadSY3
1243312O24 Pain Neutralizer 3.1 % Medicated PadSY3
1243312O24 Pain Neutralizer 31 MG/ML Medicated PadSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76433-005-012020-01-31C16284748780-19d75b9d0-b37d-f424-e053-dadaa90a57ce41da6725-a19e-4343-b2e1-2fbf27e8167f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76433-005-01O24Essential Oil Pain Relieving1 in 1 POUCHCLOTH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76433-005O24 ESSENTIAL OIL PAIN RELIEVING (CAMPHOR) CLOTH [REVIVE BIOSCIENCE, INC.]3Legacy NDC, 1 package rows20120201_41da6725-a19e-4343-b2e1-2fbf27e8167f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET3
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6623
LEMON OILINACTIVE INGREDIENTI9GRO824LL3
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH3
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3933

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76433-00576433-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662IACT
LEMON OILI9GRO824LLIACT
ORANGE OILAKN3KSD11BIACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARY OIL8LGU7VM393IACT

Source Document#

Source XML · Source PDF

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BPOWDER, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 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 PRESSEDAKN3KSD11BTABLET, CHEWABLE / ORAL3.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BSUSPENSION / ORAL1 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET / SUBLINGUALNAExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BLIQUID / ORAL50 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 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
0e7ddd10-34a5-4e0b-ae7f-528346e5eb7a41da6725-a19e-4343-b2e1-2fbf27e8167f2012-01-26WarningsExact identifier
spl id: 0e7ddd10-34a5-4e0b-ae7f-528346e5eb7a
spl set id: 41da6725-a19e-4343-b2e1-2fbf27e8167f

Reported adverse events (FAERS/openFDA)#

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