Label: KT RECOVERY PLUS PAIN RELIEF GEL- camphor, menthol gel

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

Drug Label Information

Updated November 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Camphor (5%) External Analgesic

    Menthol (5%) External Analgesic

  • PURPOSE

    Uses:

    for the temporary relief of minor aches and pains of muscles and joints due to:

    * simple backache * arthritis * sprains * strains * bruises

  • KEEP OUT OF REACH OF CHILDREN

    Warnings:

    * for external use only * do not apply to wounds or damaged skin or bandage tightly * avoid contact with eyes * Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately * 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 physician * Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use * do not bandage tightly

  • INACTIVE INGREDIENT

    Inactive Ingredients:



    distilled water, hamamelis virginiana (witch hazel extract),

    ethanol alcohol, arnica Montana, oleyl alcohol and

    zanthoxylum alatum (scezhuan pepper), Bio-saccharide

    Gum -1, glycerin, ammonium acryloyldimethyltaurate/VP

    copolymer, beta cyclodextrin, menthol, potassium hydroxide,

    mannitol, cellulose chromium, hydroxide green, tocopheryl

    acetate (vitamin E), hydroxypropyl methycellulose

  • DOSAGE & ADMINISTRATION

    Directions:

    for adults and children 2 years and older; apply to affected area not more than 3 to 4 times daily. "Children under 2 years of age: consult a doctor." Apply generously to affected and surrounding areas. Rub in well. Use 1 application for minor pain, 2 for medium and 3 applications for severs symptoms. Allow to dry between applications (usually just 2-3 minutes).

  • INDICATIONS & USAGE

    Directions:

    for adults and children 2 years and older; apply to affected area not more than 3 to 4 times daily. "Children under 2 years of age: consult a doctor."  Apply generously to affected and surrounding areas.  Rub in well. Use 1 application for minor pain, 2 for medium and 3 applications for severs symptoms.  Allow to dry between applications (usually just 2-3 minutes).

    Uses:

    for the temporary relief of minor aches and pains of muscles
    and joints due to:

        * simple backache
        * arthritis
        * sprains
        * strains
        * bruises

  • WARNINGS

    Warnings:



    * for external use only

    * do not apply to wounds or damaged skin or bandage tightly

    * avoid contact with eyes

    * Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately

    * if condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a physician

    * Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use

    * do not bandage tightly

  • PRINCIPAL DISPLAY PANEL

    Tube displayAn image/jpeg of the container label is included in this section.

  • INGREDIENTS AND APPEARANCE
    KT RECOVERY PLUS PAIN RELIEF GEL 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73044-102(NDC:10842-102)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MANNITOL (UNII: 3OWL53L36A)  
    EUPHORBIA ANTISYPHILITICA WHOLE (UNII: 82A88H0RIQ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-10 CAPRYLATE (UNII: YS396CQX5C)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73044-102-035 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2019
    2NDC:73044-102-01100 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2019
    3NDC:73044-102-0289 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2019
    Labeler - KT Health LLC (807008037)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Blending Specialists085704438manufacture(73044-102)
    Establishment
    NameAddressID/FEIBusiness Operations
    United Laboratories Manufacturing, LLC807878116manufacture(73044-102) , relabel(73044-102)
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