Label: LIP REMEDY MEDICINAL LIP BALM- petrolatum stick
LIP REMEDY MEDICINAL LIP BALM- petrolatum stick
LIP REMEDY MEDICINAL LIP BALM- petrolatum stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 22, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Petrolatum 32.3%

  • Purposes

    Skin Protectant

  • Uses

    • temporarily protects and helps relieve chapped, cracked lips
    • temporarily protects lips from drying effects of wind and cold weather
  • Warnings

    • For external use only

    When using this product keep out of eyes.

    Stop use and ask a doctor if

    • irritation or rash occurs
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply as needed.
  • Other information

    • store at 20-25°C (68-77°F)

    • this is a personal care item and should be used by one individual
    • You may report a serious adverse reaction to this product to: GANZ U.S.A., LLC, #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903
  • Inactive ingredients

    isopropyl lanolate, lanolin, ozokerite wax, euphorbia cerifera (candelilla) wax, isopropyl myristate, polybutene, diisopropyl adipate, myristyl myristate, flavor, theobroma cacao (cocoa) seed butter, camphor, menthol, phenol, yellow 10 lake, red 6 lake, saccharin, menthoxypropanediol

  • PRINCIPAL DISPLAY PANEL - 4 g Blue Carton

    Net wt. 4 g (0.14 Oz.)

    time & again®
    LIP REMEDY medicinal lip balm
    with Menthol and Cocoa Seed Butter

    Soothes, relieves
    and helps to protect
    dry chapped lips.

    Principal Display Panel - 4 g Blue Carton
  • PRINCIPAL DISPLAY PANEL - 4 g Green Carton

    Net wt. 4 g (0.14 Oz.)

    time & again®
    LIP REMEDY medicinal lip balm
    with Menthol and Cocoa Seed Butter

    Soothes, relieves
    and helps to protect
    dry chapped lips.

    Principal Display Panel - 4 g Green Carton
  • PRINCIPAL DISPLAY PANEL - 4 g Red Carton

    Net wt. 4 g (0.14 Oz.)

    time & again®
    LIP REMEDY medicinal lip balm
    with Menthol and Cocoa Seed Butter

    Soothes, relieves
    and helps to protect
    dry chapped lips.

    Principal Display Panel - 4 g Red Carton
  • INGREDIENTS AND APPEARANCE
    LIP REMEDY MEDICINAL LIP BALM   BLUE
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOL (UNII: 339NCG44TV)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-012-501 in 1 BOX
    14 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/01/2011
    LIP REMEDY MEDICINAL LIP BALM   GREEN
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOL (UNII: 339NCG44TV)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-013-501 in 1 BOX
    14 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/01/2011
    LIP REMEDY MEDICINAL LIP BALM   RED
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHENOL (UNII: 339NCG44TV)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-014-501 in 1 BOX
    14 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/01/2011
    Labeler - Norwood Packaging Ltd. (243693926)
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