Label: ARNEU- camphor menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 28, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor 3.100%

    Menthol 3.000%

  • PURPOSE

    Purpose

    Topical Analgesic

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints.

    Penetrating pain relief.

  • WARNINGS

    Warnings

    For external use only.

    Do not bandage tightly.

    Do not apply heat to the area of application.

    Do not apply to open wounds or damaged skin.

    Avoid contact with eyes or mucous membranes.

    Ask a doctor before use, if you have ever experienced a reaction due to ingredients listed.

    Stop use and consult a licensed health professional if conditions worsens or if symptoms persists for more than 7 days, or clears up and occurs again.

    If pregnant or breast feeding, ask the health professional before use.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age or older

    Apply to surface, leaving a thin visible film; by applying a thicker film, the intensity is increased.

    Apply to the area of pain, extending outside of the area slightly.

    Apply 2 times a day minimum (do not exceed application of 4 times daily).

    Allow to dry completely before applying loose clothing over the area.

    Directions

    (Children 12 years of age or younger)

    Ask your doctor or a licensed health professional.

  • STORAGE AND HANDLING

    Other Information

    Store at 15-30 C (50-85 F). Keep sealed tightly.

    No triethanolamine used in manufacturing.

    Have all medical diagnosis confirmed by a healthcare professional before treating.

    Do not use if cap seal has been tampered with.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, propylene glycol, glycerin, witch hazel, carbomer, sodium hydroxymethylglycinate, fragrance, arnica montana flower extract, potassium asparate, sodium chlorite, willow bark extract, green tea leaf extract, sodium hydroxide, spirulina maxima extract, aloe vera leaf juice, ginger root extract, bromelain, boswellia serrata gum, sodium sesquicarbonate, sodium bicarbonate, capsaicin (capsicum frutescens fruit extract).

  • PRINCIPAL DISPLAY PANEL

    ArNeu

    penetrating pain relief

    God Formula

    Topical Analgesic Counterirritant

    For the Temporary Relief of Minor Aches and Pains of Muscles and Joints

    NET WT. 3.0 OZ. (85 g.)

    www.arneu.com

    NDC 42046-002-03

    US Pat.7,704,522 and Pat. Pending

    Made in USA

    container label


  • INGREDIENTS AND APPEARANCE
    ARNEU 
    camphor menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42046-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)3.1 g  in 100 g
    Menthol (UNII: L7T10EIP3A) (Alcohol - UNII:3K9958V90M) Menthol3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Witch Hazel (UNII: 101I4J0U34)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Potassium Aspartate (UNII: OC4598NZEQ)  
    Sodium Chlorite (UNII: G538EBV4VF)  
    Willow Bark (UNII: S883J9JDYX)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Ginger (UNII: C5529G5JPQ)  
    Bromelains (UNII: U182GP2CF3)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Capsaicin (UNII: S07O44R1ZM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42046-002-0385 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/28/2010
    Labeler - CC Medical Devices Inc (121825868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gar Laboratories074933615manufacture
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