Label: PRO-FLEX- camphor, menthol 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 20, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients (Percent by weight)           Purpose

    Menthol  4.0%  ............................Analgesic              (Pain reliever)

    Camphor 4.0%  ...........................Analgesic               (Pain reliever)


  • INDICATIONS & USAGE

    Uses for the temporary relief of minor aches and joint pain associated with backpain, arthritis, strains, bruises and sprains.

  • WARNINGS

    Warnings

    • For external use only.  Avoid contact with eyes.  If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,discontinue use of this product and consult a doctor.
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older:  Apply to affected area several times daily.
    • Children under 2 years of age:  Do not use, consult a doctor.
  • INACTIVE INGREDIENT

    C13-14 isoparaffin, caprylyl glycol, cetyl alcohol, chondroitin sulfate, denatured alcohol, eucalyptus oil, glucosamine sulfate, glycerin, grape seed oil, laureth-7, methylsulfonylmethane (MSM), oil of lavender, oil of wintergreen, phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic, acid, stearyl alcohol, thymol, urea, vitamin E, water


  • REFERENCES

    Distributed by:

    PROFESSIONAL HEALTH PRODUCTS

    4307-49th Street    Innisfail, AB  CANADA T4G 1P3

    1-403-227-3926

  • PURPOSE



    Pain Reliever


  • PRINCIPAL DISPLAY PANEL

    Professional Health Products

                        PRO-FLEX Cream

                                FOR

                          Muscle Pain/Joint Relief

              (Includes MSM, Glucosamine, Chondroitin)

    120 net wt. g



    www.professionalhealthproducts.com

    image of pro-flex label



  • INGREDIENTS AND APPEARANCE
    PRO-FLEX  
    camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49795-227
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    Glycol stearate (UNII: 0324G66D0E)  
    Dimethyl sulfone (UNII: 9H4PO4Z4FT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearyl alcohol (UNII: 2KR89I4H1Y)  
    Glucosamine sulfate (UNII: 1FW7WLR731)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Urea (UNII: 8W8T17847W)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl glycol (UNII: 00YIU5438U)  
    Sorbic acid (UNII: X045WJ989B)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    Methyl salicylate (UNII: LAV5U5022Y)  
    Vitamin E (UNII: H4N855PNZ1)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Thymol (UNII: 3J50XA376E)  
    Chondroitin sulfate (bovine) (UNII: 6IC1M3OG5Z)  
    CUCUMARIA SEA CUCUMBER (UNII: 3SC3X5I2GC)  
    Grape seed oil (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49795-227-01120 g in 1 JAR
    2NDC:49795-227-02500 g in 1 BOTTLE, PLASTIC
    3NDC:49795-227-035 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2004
    Labeler - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)
    Registrant - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Laboratories (Canada) Ltd.247010150manufacture
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