Label: INSTANT ANTISEPTIC PAIN RELIEF- camphor 10.8% and phenol 4.7% liquid

  • NDC Code(s): 63868-060-45
  • Packager: Chain Drug Market Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Camphor 10.8%, Phenol 4.7 %

  • Purpose

    Pain Reliever, Antiseptic

  • Uses:

    Helps prevent infection and temporarily relieves pain and itching in minor burns, cuts, insect bites, scrapes, sunburn and other minor skin irritations.

  • Warnings:

    For External Use Only. Do not induce vomiting. If vomiting occurs give fluids again. Do not use in or near the eyes: In case of eye contact, flush eyes with running water for 15 minutes, get medical attention immediately. Do not use on: deep punture wounds, animal bites, serious burns.

  • When using this product:

    Do not bandage. Do not use over large areas of the body.

  • Stop use and consult a doctor if:

    Condition worsens. Symptoms last more than 7 days or clear up and occur again in a few days.

  • Keep out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    Adult and children 2 yrs and older: apply to affected area 1 to 3 times daily.

    Children under 2 yrs of age: Consult a doctor before use.

  • Inactive ingredients:

    Citric acid, Eucalyptus Oil, Light Mineral Oil

  • Principal display panel

    QCIAPR.jpgCapture

  • INGREDIENTS AND APPEARANCE
    INSTANT ANTISEPTIC PAIN RELIEF 
    camphor 10.8% and phenol 4.7% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)108 mg  in 1 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL47 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-060-4545 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2008
    Labeler - Chain Drug Market Association (011920774)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(63868-060) , manufacture(63868-060) , analysis(63868-060) , pack(63868-060)
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