Label: DG HEALTH COLD N HOT PAIN RELIEVING TOPICAL ANALGESIC- menthol, unspecified form liquid

  • 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 26, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 16%

  • 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. Test on a small patch of skin before applying generously.

    When using this product

    ♦
    use only as directed
    ♦
    avoid contact with the eyes and mucous membranes
    ♦
    do not apply to wounds or damaged skin
    ♦
    do not bandage tightly
    ♦
    do not use with heating pads or other heating devices
    ♦
    if redness is present, discontinue use and consult a doctor
    ♦
    if skin irritation occurs, discontinue use
    ♦
    a transient burning sensation may occur upon application but generally disappears in several days

    Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Flammable

    ♦
    keep away from fire or flame

    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 immediately.

  • Directions

    adults and children 12 years of age and older:

    ♦
    apply generously to affected area
    ♦
    massage into painful area until thoroughly absorbed into skin
    ♦
    repeat if necessary, but not more than 3 to 4 times daily
    ♦
    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

    Children 12 years or younger: ask a doctor

  • Other information

    store at room temperature

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

  • Questions or comments?

    1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY DOLGENCORP, LLC
    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

  • PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

    DG™ | health

    Compare
    to active
    ingredient
    of IcyHot®*

    Cold'n Hot

    Pain Relieving Liquid
    Menthol 16%

    • Powerful, fast and
      effective pain relief
    • No-mess applicator
    • Stain-free

    2.5 FL OZ (74 mL)

    PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DG HEALTH COLD N HOT PAIN RELIEVING  TOPICAL ANALGESIC
    menthol, unspecified form liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-883
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Alcohol (UNII: 3K9958V90M)  
    Capsaicin (UNII: S07O44R1ZM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-883-011 in 1 CARTON12/27/2019
    174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/27/2019
    Labeler - Dolgencorp Inc (068331990)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(55910-883)
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