Label: SUSTAFIX- camphor cream

  • 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 October 27, 2021

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  • Active Ingredient

    Camphor 1.00%

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only. Contains bee venom.

  • Do Not use

    In large quantities, particularly over raw surfaces or blistered areas.• If condition worsens or if symptoms persist for more than 7 days or clear up and ocur again within a few days, discontinue use of this product and consult a doctor.

  • When Using This Product

    Avoid contact with the eyes

  • Stop using and Ask a Doctor

    if irritation or rash occurs.

  • Keep Out Of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • Other Information

    Keep dry. Store at 15°C and 30°C. Avoid direct sunlight.

  • Inactive Ingredients

    Acetylated glycol stearate, Aesculus hippocastanum extract, Amica montana flower extract, Beezwax, Benehyl alcohol, Butyrospermum parkii butter, Ceteth-251 Cet:yl alcohol, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Ethylhexyl stearate, EucalypbJs globulus leaf oil, Harpagophytum procumbens root extract, Limonen, Linalool, PEG-9 stearate, Phenoxyethanol, Propolis extract, Propylene glycol, Rosmarinus officianalis leaf oil, Sesamum indicum seed oil, Sodium polyacrylate, Trideceth-61 Water, Bee venom, BHT1 Methyl nicotinate

  • Principal Display

    Made in the EU

    Manufacturered for Likasso, LTD

    Grafenberger Alle 115

    4023 Dusseldorf, Germany

    NDC: 82225-002-10

    tube

    box

  • INGREDIENTS AND APPEARANCE
    SUSTAFIX 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82225-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M)  
    CETETH-25 (UNII: 5KLY4IOG20)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    APIS MELLIFERA VENOM (UNII: 76013O881M)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
    PEG-9 STEARATE (UNII: WZU67V0H4I)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    SESAMUM INDICUM WHOLE (UNII: JD6YPE8XLT)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82225-002-101 in 1 BOX10/27/2021
    1100 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 finalpart34810/27/2021
    Labeler - Hakimian Global LLC (117010019)
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