Label: ARTHRITIS PLUS GEL- camphor, menthol, methyl salicylate 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 June 5, 2013

If you are a consumer or patient please visit this version.

  • INACTIVE INGREDIENT

     Inactive Ingredients

    Aloe vera gel, amica montana (flower extract), cetaryl alcohol, clove oil,

    diazolidimyl urea, FD C Blue #1,  frangrance, ginger oil, lavender oil,

    methylsulfonylmethane (MSM), Methyl paraben, orange oil.

    peppermint oil, polysorbate 60, propylene glycol, propylparaben,

    purified water, rosemary oil, thyme oil, Vitamin C,

    Vitamin E, xanthan gum

  • ACTIVE INGREDIENT

    Active Ingredients

    Camphor 3%

    Methol 12%

    Methyl Salicylate 15%

  • PURPOSE

    Purpose

    Topical Analgesic

    Counterirritant

    Counterirritant

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    -Simple Backache

    -Arthritis

    -Sprains

    -Strains

    -Bruises

  • WARNINGS

    Warnings:

    For external use only. Avoid contact with

    eyes and mucous membranes

    -If condition worsens or if symptoms persist for more than 7 days

    or clear up and appear again within a few days, discontinue use of this

    product and consult a doctor.

    -When used for arthritis, if pain persists for more than 10 days or redness

    is present or in conditions affecting children under 12 years of age, consult

    a physician immediately.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach of children: If swallowed, get immediate

    medical help or contact poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older:

    apply to the affected area, massage for 1 minute,

    use not more than 3-4 times daily, wash hands.

    Children under 12 years of age: Consult a physician


  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PLUS GEL  
    camphor, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50810-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 mg  in 100 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CLOVE OIL (UNII: 578389D6D0)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYME OIL (UNII: 2UK410MY6B)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50810-2000-11 in 1 BOX
    157 mg in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2013
    Labeler - JI Well Health Company (005624801)