Label: PAINONIL- eugenol, camphor, eucalyptus ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 24, 2021

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  • PainONil Active Ingredients

    Active Ingredient

    Strength

    Purpose

    Camphor

    8%

    External analgesic

    Eucalyptus oil

    5%

    External analgesic
    Eugenol2%Analgesic & Anesthetic

  • Purpose

    For rapid and sustained relief of pain.

  • 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

  • Warnings

    • 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

    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 DrugFact

  • When Using This Product

    • Do not apply excessive external heat

  • Stop Use Section

    Stop use of this product and consult a doctor If:

    • Skin rash occurs

  • If pregnant or breat feeding

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

  • Keep Out of Reach of Children

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

  • Other 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 Label

  • Inactive Ingredients

    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 ?

    PainONil Contact

  • Principal Display Panel - 25 g Tube & Carton

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

    Net Wt: 0.90 OZ (25g)

    PainONil Outer Label

  • INGREDIENTS AND APPEARANCE
    PAINONIL 
    eugenol, camphor, eucalyptus ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73417-758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)80 mg  in 1 g
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL20 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FENUGREEK SEED (UNII: 654825W09Z)  
    MUSTARD OIL (UNII: TYY1MA9BSY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    RUBIA CORDIFOLIA ROOT (UNII: 4V873H15CG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TURMERIC (UNII: 856YO1Z64F)  
    ONION JUICE (UNII: 77539R6FGN)  
    GINGER (UNII: C5529G5JPQ)  
    ANISE OIL (UNII: 6Y89129C8H)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73417-758-521 in 1 CARTON08/12/2021
    125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/12/2021
    Labeler - PhytoBiologic Pharmaceutics LLC (117103844)
    Registrant - PhytoBiologic Pharmaceutics LLC (117103844)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytoBiologic Pharmaceutics LLC117103844manufacture(73417-758) , label(73417-758)
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