Label: HEB CAMPHOR PHENOL- camphor 10.8% and phenol 4.7% liquid

  • 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 March 16, 2022

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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

  • Package

    Carton

  • INGREDIENTS AND APPEARANCE
    HEB CAMPHOR PHENOL 
    camphor 10.8% and phenol 4.7% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-105
    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:37808-105-0545 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2008
    Labeler - H E B (007924756)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(37808-105) , manufacture(37808-105) , pack(37808-105) , analysis(37808-105)
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