Label: CIRLUTONE- camphor 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 December 6, 2017

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  • ACTIVE INGREDIENT

    Camphor 0.6%

  • PURPOSE

    Camphor 0.6%...............Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of pain associated with:

    • sunburn
    • minor cuts
    • scrapes
  • WARNINGS

    For External Use only.

    Flammable: keep away from fire or flame

    When using this product

    • avoid contact with eyes or mucous membrane
    • use only as directed

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • Children under 2 yrs of age: consult a doctor.
  • STORAGE AND HANDLING

    • Store in a cool & dry place
    • Do not use if tamper evident seal is broken or missing
  • INACTIVE INGREDIENT

    Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum

  • QUESTIONS

    Call 310-888-8878 Monday through Friday, 9am-5pm CST.

  • DESCRIPTION

    Herbal Health L.L.C.
    Made in the U.S.A.
    www.cirlutone.com

  • DESCRIPTION

    Exp. Date:

    Lot No.:

    Manufactured by:

    Neutraderm, Inc.

    20660 Nordhoff St.

    Chatsworth, CA. 91311

    info@cirlutone.com

    www.cirlutone.com

  • PRINCIPAL DISPLAY PANEL

    CIRLUTONE

    Ointment

    Topical Analgesic

    Net Wt. 3.53oz/100g.

    CirlutoneCarton

  • INGREDIENTS AND APPEARANCE
    CIRLUTONE 
    camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71917-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA ANOMALA WHOLE (UNII: T1F4GB8MNL)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGUSTICUM WALLICHII WHOLE (UNII: 8Y1N3NX2DW)  
    MAGNOLIA LILIIFLORA WHOLE (UNII: GDO2997SZZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71917-001-35100 g in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/06/2017
    Labeler - Herbal Health LLC (080764759)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neutraderm, Inc.146224444manufacture(71917-001)
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