KISS THERAPY MEDICATED LIP BALM (CAMPHOR, MENTHOL, PETROLATUM) STICK [MARKWINS BEAUTY PRODUCTS, INC.]

KISS THERAPY MEDICATED LIP BALM (CAMPHOR, MENTHOL, PETROLATUM) STICK [MARKWINS BEAUTY PRODUCTS, INC.]
PDF | XML

NDC 12027-208-01, 12027-208-02
Set ID 589e1060-27da-5c4d-e053-2991aa0a1d07
Category HUMAN OTC DRUG LABEL
Packager Markwins Beauty Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • DOSAGE & ADMINISTRATION

    Dosage and Administration

  • WARNINGS

    Warnings

  • INACTIVE INGREDIENT

    Inactive ingredients

  • INDICATIONS & USAGE

    Indication and usage

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    Purpose

  • ACTIVE INGREDIENT

    Active Ingredient

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    KISS THERAPY MEDICATED LIP BALM 
    camphor, menthol, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.8 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-208-021 in 1 BLISTER PACK09/07/2017
    1NDC:12027-208-013.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/07/2017
    Labeler - Markwins Beauty Products, Inc. (135407760)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baja Fur, S.A. de C.V.821533098manufacture(12027-208) , label(12027-208) , pack(12027-208)

Related Drugs