Label: REPAIR AND PROTECT- 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 July 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Petrolatum 45.0% (w/w)

  • Purpose

    Lip protectant

  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last 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

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    beeswax, butylene glycol, butyrospermum parkii (shea) butter, chamomilla recutita (matricaria) flower extract, ethylhexyl palmitate, helianthus annuus (sunflower) seed oil, lanolin, microcrystalline wax, octyldodecanol, ozokerite, paraffin, persea gratissima (avocado) oil, phenoxyethanol, phenyl trimethicone, silica dimethyl silylate, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

    Blistex®
    NEW
    Lip Protectant

    DERMATOLOGIST RECOMMENDED*

    REPAIR &
    PROTECT

    Relieves and Protects
    Severely Dry, Chapped Lips

    Smooth Formula for
    Long-Lasting Moisture

    Net Wt. 0.13 oz. (3.69 g)

    PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    REPAIR AND PROTECT 
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1189-11 in 1 BLISTER PACK07/05/2023
    13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/05/2023
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-1189)
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