Label: JOINTFLEX- camphor 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 January 18, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Camphor (3.2%)

  • Purpose

    Topical analgesic

  • Uses:

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings:

    For external use only.

  • Do not use

    • if skin is irritated or damaged
    • excessive irritation develops
    • 12 years of age or under
  • Ask a doctor befor use if you have

    • redness over the affected area
  • When using this product

    • use only as directed
    • avoid contact with the eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • do not bandage tightly or use a heating pad
    • do not swallow
  • Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness develops
  • Keep out of reach of children.

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

  • Directions:

    Rotate the massager head to ON position and squeeze tube gently to dispense. Return the massager head to OFF position. Using a circular pattern, gently massage over the pain inflicted area using the built-in roller balls until the Emulsion Gel disappears.

    adults and children 12 years of age and older:
    • clean, rinse and dry skin prior to application
    • apply generously to painful muscles and joints, gently massaging until the JointFlex® Night Time Pain Relief Emulsion Gel disappears
    • repeat as necessary, but no more than 4 times a day
    • for optimum benefit, use daily for at least two weeks and continue to use daily thereafter
    children under 12 years of age:
    • ask a doctor
  • Other information:

    • store at room temperature with the cap closed
    • notice: because this product contains natural ingredients, color may vary
  • Inactive ingredients:

    Acetylated Lanolin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Dimethiconol Stearate, Disodium EDTA, dl Panthenol, Fragrance, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropyl Methycellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

  • Questions or comments?

    Call (866) 235-4581 or email stridesconsumer@emersongroup.com

    Manufactured for

    Strides Consumer LLC,

    East Brunswick, NJ 08816

    Licensed user of trademarks. ©2022 Strides Consumer LLC

    †Results based on a 2021 Healthcare Provider survey conducted by InStep Health as part of a point-of-care marketing campaign sponsored by Strides Consumer LLC.

    www.jointflex.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Flex Your FreedomTM

    Visit www.jointflex.com for more information

    DEEP PENETRATING Fusome® Technology

    Quick & effective penetration

    Targeted pain relief

    Long lasting relief when used daily

    Roller-FlexTM Massager gently works to reduce pain right at the source

    Roller-FlexTMMassager

    Innovative Massage Applicator

    #1 CLINICALLY RECOMMENDED JOINT PAIN CREAM

    Effectively Reduces Joint Pain

    Immediate & Long Lasting Relief*

    Relaxing** Lavender DreamScentTM

    Contains Glucosamine & Chondroitin for skin conditioning

    NDC 72927-976-02

    NET WT 3.5 OZ (99g)

    Night Time Pain Relief

    Back, Neck & Shoulde

    Knee & Elbow

    Foot, Ankle, Leg

    Hand & Wrist

    *When applied as directed

    **fragrance technology validated using Sandman Classifier Test

    Roller-FlexTMMassager

    5 Stainless steel rollerballs

    Deep pressure massage applicator

    Cool to the touch

    Targeted pain relief

    Night Time Pain Relief Emulsion Gel

    TUBES ARE FILLED BY WEIGHT NOT VOLUME

    011-1650C-R01

    JointFlex Lavender
  • INGREDIENTS AND APPEARANCE
    JOINTFLEX 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72927-976
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETYLATED LANOLIN (UNII: 2X654GD19H)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYLATED LANOLIN (UNII: EOI0B9800C)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHARK CARTILAGE (UNII: D2YCN1I522)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72927-976-021 in 1 CARTON06/01/2021
    199 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2021
    Labeler - Strides Consumer LLC (116975770)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beltapharm SPA429236789MANUFACTURE(72927-976) , PACK(72927-976)