Label: OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL- medicated lip repair stick

  • NDC Code(s): 65692-0309-1, 65692-0310-1
  • Packager: Raining Rose, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient: Petrolatum 30%

  • PURPOSE

    Purpose

    Lip protectant

  • INDICATIONS & USAGE

    Uses
    • Helps prevent and temporarily protects chapped or cracked lips.
    • Helps prevent and protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask 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.

  • DOSAGE & ADMINISTRATION

    Directions apply as needed

  • OTHER SAFETY INFORMATION

    Other Information ​​Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    ​INACTIVE INGREDIENTS: Beeswax, Butyrospermum ParkII (Shea) Butter, Dimethicone,

    Hydrogenated Poly (C6-14 Olefin), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Salvia

    Hispanica (Chia) Seed Oil, Trimethylpentanediol/Adipic Acid/Glyerin Crosspolymer,

    Polysilicone-11, Menthyl Nicotinate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil,

    Ethylene/Propylene/Styrene, Copolymer, Sodium Saccharin, Butylene/Ethylene/Styrene

    Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

  • Principal Display Package

    O'KEEFFE'S MEDICATED LIP REPAIR SEAL & HEAL

    Distributed by O'Keeffe's Company, Cincinnati, OH 45241

    Questions/Comments: 1-800-275-2718

    Lip Repair

    image description

    1-Stick Package

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    2-Stick Package

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  • INGREDIENTS AND APPEARANCE
    OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL 
    medicated lip repair stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.26 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0309-11 in 1 BLISTER PACK03/01/2022
    14.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2022
    OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL 
    medicated lip repair stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.26 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0310-12 in 1 BLISTER PACK03/01/2022
    14.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2022
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
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