Label: ICY HOT KIDS PAIN RELIEF ROLL-ON- menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Icy Hot Kids Pain Relief Roll-On

    Drug Facts

  • Active ingredient

  • Purpose

    Menthol 4%.........................................................................................................................Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with:    ■ strains

    ■ sprains ■ bruises ■ simple backache    

  • Warnings

    For external use only

    Do not use

    ■ on wounds or on irritated or damaged skin

    ■ with a heating pad

    When using this product

    ■ use only as directed

    ■ do not bandage tightly

    ■ avoid contact with eyes and mucous membranes

    ■ do not expose the area to local heat or to direct sunlight

    ■ rare cases of serious burns have been reported with products of this type

    ■ a transient burning sensation may occur upon application but generally disappears in several days

    ■ avoid applying into skin folds

    Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    ■ redness is present or excessive skin irritation occurs

    ■ you experience severe burning pain, swelling, or blistering where the product was applied

    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 right away.

  • Directions

    ■ children 2 years of age and older: 

          ■ apply a thin layer to affected area not more than 3 to 4 times daily

          ■ massage until thoroughly absorbed into skin

          ■ wash hands thoroughly with soap and water after each use

    ■ children under 2 years of age: ask a doctor

  • Inactive ingredients

    allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water

    PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION. Close cap tightly after use.

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    Icy Hot
    Kids Pain Relief
    Roll-On
    1.5 FL OZ (44.3 mL) ROLL-ON

    PRINCIPAL DISPLAY PANEL Icy Hot Kids Pain Relief Roll-On 1.5 FL OZ (44.3 mL) ROLL-ON

  • INGREDIENTS AND APPEARANCE
    ICY HOT KIDS PAIN RELIEF ROLL-ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0799
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0799-01 in 1 CARTON01/15/2023
    144.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2023
    Labeler - Chattem, Inc. (003336013)
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