Label: GELLERT JOINT CARE- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL

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 1, 2012

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  • Active ingredients

    Capsaicin 0.17%

  • Purpose

    External Analgesic

  • INDICATIONS & USAGE

    Uses temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, muscle strains, sprains and bruises.

  • Warnings

    For external use only

    Do Not Use

    • on wounds or damaged skin
    • with tight bandages

    When using this product

    • avoid contact with the eyes and mucous membranes

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • skin redness or excessive irritation of the skin develops

    • if pregnant or breast-feeding, ask a health professional before use.

    • 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 a thin layer to the affected area in the morning and evening on dry clean skin
    • Recommended use for at least two weeks consistently
    • Children under 2 years of age: consult a physician
  • Other information

    • Store below 25°C (77°F)
    • This package has a tamper-evident seal. If the seal is broken, do not use
  • INACTIVE INGREDIENT

    Inactive Ingredients Ascorbic Acid (Vitamin C), Cetyl alcohol, Distilled water, Glucosamine sulphate, Methylparaben, Methylsothiazolinone, Methylsulfonylmethane, Natural triglycerides (Omega-3), Peppermit extract, Polyethyleneglycol esters.

  • Questions?

    Call 1 (888) 434-2235; 9am - 5pm EST

    Or visit: www.GellertHealth.com

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Gellert Joint Care - 45g Carton

    Principal Display Panel - Gellert Joint Care - 45g Carton

  • INGREDIENTS AND APPEARANCE
    GELLERT JOINT CARE 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49834-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 73.748 g  in 100 g
    Glucosamine Sulfate (UNII: 1FW7WLR731) 8 g  in 100 g
    Octanoic Acid (UNII: OBL58JN025) 8 g  in 100 g
    Glyceryl Monostearate (UNII: 230OU9XXE4) 3 g  in 100 g
    Butylene Glycol (UNII: 3XUS85K0RA) 1.8 g  in 100 g
    Cetyl Alcohol (UNII: 936JST6JCN) 1.5 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) 0.8 g  in 100 g
    Methylparaben (UNII: A2I8C7HI9T) 0.12 g  in 100 g
    Peppermint Oil (UNII: AV092KU4JH) 0.05 g  in 100 g
    Methylisothiazolinone (UNII: 229D0E1QFA) 0.05 g  in 100 g
    Curcumin (UNII: IT942ZTH98) 0.001 g  in 100 g
    FD&C Yellow No. 5 (UNII: I753WB2F1M) 0.006 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49834-001-0148.19 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2009
    Labeler - Gellert Health Solutions LLC (832894104)
    Registrant - Gellert Health Solutions LLC (832894104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Licht Far East (S) Pte. Ltd.894670728manufacture
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