Label: FAMILY WELLNESS ICE BLUE- menthol gel

  • NDC Code(s): 55319-990-01
  • Packager: FAMILY DOLLAR SERVICES 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 June 1, 2020

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  • Active ingredient

    Menthol 2 percentage

  • Purpose

    External pain reliever

  • Uses

    Temporary relief of minor pains of muscle and joints associated with

    simple back ache

    arthritis

    sprains, strains or bruises

  • Warnings

    Do not use internally, with heating pads or devices, on wounds or damaged skin.

    For external use only.

    Ask a doctor before use if you have sensitive skin.

  • When using this product

    Use only as directed

    do not bandage tightly

    avoid contact with eyes and mucus membranes

  • 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

    skin irritation develops

  • If you are pregnant or nursing a baby,

    concult a physician before use.

  • KEEP OUT OF REACH OF CHILDREN.

    DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

    In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.

  • Directions

    Adult and children 2 years of age and older:

    Clean skin thoroughly. Apply liberally to affected area not more than 3-4 times daily. No protective cover needed.

    May be used with ice packs.

    May be used with wet or dry bandages, but wrap loosely.

    Children under 2 years of age, consult a doctor.

  • Other information

    store between 59 - 86 Fahrenheit (15 - 30 degrees Celsius) keep tightly closed

    do not use, pour, spill or store near heat or open flame.

  • Inactive ingredients

    Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ICE BLUE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-990
    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
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-990-01226 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2020
    Labeler - FAMILY DOLLAR SERVICES INC (024472631)
    Registrant - FAMILY DOLLAR SERVICES INC (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(55319-990)
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