FDA.reportPublic FDA data

PainONil

Manufacturer
PhytoBiologic Pharmaceutics LLC
Effective date
2021-07-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:41:51

Label at a glance#

ProductPainONil
Active ingredientCAMPHOR (NATURAL), EUGENOL, EUCALYPTUS OIL
Label structure14 sections

Indications and uses

For rapid and sustained relief of pain in joints, muscles, and tendons caused due to: Sprains sports injuries falls back & neck injuries inflammation swelling excessive use of joints

Dosage and administration

Apply a generous amount of the ointment (~1g) on the affected area 3 times daily and massage gently. For faster results*, apply mild heat at the effected area with a heat lamp or heat pad after each application. Do not use for children under 5 years of age. * Individual results may vary.

Label contents#

Full prescribing information#

PainONil Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Strength

Purpose

Camphor

8%

External analgesic

Eucalyptus oil

5%

External analgesic

Eugenol2%Analgesic & Anesthetic

Purpose

OTC - PURPOSE SECTION

For rapid and sustained relief of pain.

Uses

INDICATIONS & USAGE SECTION

For rapid and sustained relief of pain in joints, muscles, and tendons caused due to:

  • Sprains
  • sports injuries
  • falls
  • back & neck injuries
  • inflammation
  • swelling
  • excessive use of joints

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Use only as directed.
  • Stop use and consult a doctor if: Skin rash or allergy occurs.
  • If pregnant or breast-feeding, or symptoms persist, consult medical professional.
  • Keep out of children's reach. If swallowed, get immediate medical help.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a generous amount of the ointment (~1g) on the affected area 3 times daily and massage gently. For faster results*, apply mild heat at the effected area with a heat lamp or heat pad after each application.

Do not use for children under 5 years of age.


* Individual results may vary.

PainONil DrugFactPainONil DrugFact

When Using This Product

OTC - WHEN USING SECTION

  • Do not apply excessive external heat

Stop Use Section

OTC - STOP USE SECTION

Stop use of this product and consult a doctor If:

  • Skin rash occurs

If pregnant or breat feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, or symptoms persist, consult medical professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of children's reach. If swallowed, get immediate medical help.

Other Information

OTHER SAFETY INFORMATION

  • Store in room temperature 40 0F to 86 0F (4 0C to 30 0C)
  • Bioactive formula has a natural color that can stain cloths

PainONil Inner LabelPainONil Inner Label

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.

Questions or Comments ?

OTC - STOP USE SECTION

PainONil ContactPainONil Contact

RECENT MAJOR CHANGES SECTION

  • Active Ingredients (Camphor -- 8% External analgesic, Eucalyptus Oil -- 5% External analgesic, Eugenol -- 2% Analgesic & Anesthetic)
  • Inactive ingredients
    Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.

Principal Display Panel - 25 g Tube & Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PainONil TM - 25 g Tube & Carton
NDC 73417-718-25

Net Wt: 0.90 OZ (25g)

PainONil Outer LabelPainONil Outer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2566044camphor 8 % / eucalyptus oil 5 % / eugenol 2 % Topical OintmentPSN5
2566044camphor 0.08 MG/MG / Eucalyptus oil 0.05 MG/MG / eugenol 0.02 MG/MG Topical OintmentSCD5
2566044camphor 8 % / eucalyptus oil 5 % / eugenol 2 % Topical OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EUGENOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73417-758-522023-01-30C16284748780-1f386c649-c041-0266-e053-dadaa90a7c1aPainONil 25g Tube for Sustained and Rapid Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73417-758-52PainONil25 g in 1 TUBEOINTMENT255
73417-758-52PainONil1 in 1 CARTONOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73417-758PAINONIL (EUGENOL, CAMPHOR, EUCALYPTUS) OINTMENT [PHYTOBIOLOGIC PHARMACEUTICS LLC]5Legacy NDC, 2 package rows20210812_c62451b0-771e-a774-e053-2995a90a37d8.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73417-75873417-758-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FENUGREEK SEED654825W09ZIACT
MUSTARD OILTYY1MA9BSYIACT
PETROLATUM4T6H12BN9UIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUGENOL3T8H1794QWACTIB
PEPPERMINT OILAV092KU4JHIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
YELLOW WAX2ZA36H0S2VIACT
RUBIA CORDIFOLIA ROOT4V873H15CGIACT
EUCALYPTUS OIL2R04ONI662ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
TURMERIC856YO1Z64FIACT
ONION JUICE77539R6FGNIACT
GINGERC5529G5JPQIACT
ANISE OIL6Y89129C8HIACT

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
c7df0ca8-1f2f-556f-e053-2995a90a195ec62451b0-771e-a774-e053-2995a90a37d82021-07-24WarningsExact identifier
spl id: c7df0ca8-1f2f-556f-e053-2995a90a195e
spl set id: c62451b0-771e-a774-e053-2995a90a37d8

Reported adverse events (FAERS/openFDA)#

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