Label: ICE MUSCLE RUB LEON M.C- menthol gel

  • NDC Code(s): 69822-103-08
  • Packager: Southern Sales & Service, Inc.
  • 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 January 4, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredients               Purpose

    Menthol 2.0%                    Topical Anagesic

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

     temporary relief minor pains due to:

    • Arthritis
    • Muscle Strains
    • Minor Backaches
    • Sprains
    • Cramps
    • Bruces
  • WARNINGS

    Warnings

    For external use only

    When using this product

    • Keep away from eyes and Mouthdo not bandage tightly
    • Do not apply to wounds or broken skin
    • Do not bandage or use with heating pad.

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children over 12 years:

    • Aapply to affected area and massage until Gel is absorved
    • Repeat as necesary but no more than 4 times daily
    • Children 12 years or younger:Ask your doctor
  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

  • Distributed by

    Leon Medical Centers, Ic.

    Miami, FL 33165

    Question or Comments?

    Call 1 800.213.9370

  • Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Irritation develops
  • Leon Medical Muscle Rub Gel

    Label Image
  • INGREDIENTS AND APPEARANCE
    ICE MUSCLE RUB LEON M.C 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-103-08 227 g in 1 TUBE; Type 0: Not a Combination Product01/04/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Southern Sales & Service, Inc. (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Service, Inc.013114906LABEL(69822-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(69822-103)