Label: OKEEFFES LIP REPAIR SEAL AND HEAL- petrolatum stick

  • NDC Code(s): 71564-005-42, 71564-005-84
  • Packager: The Gorilla Glue Company/O'Keeffe's Company
  • 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 January 1, 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 a doctor if

    • conditions worses
    • 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

  • STORAGE AND HANDLING

    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/Glycerin 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

  • QUESTIONS

    Questions or comments? 1-800-275-2718

  • SPL UNCLASSIFIED SECTION

    Repairs and heals extremely dry, cracked lips

    Lip Representative Photos: Two week usage period. Lip balm was applied according to package directions. Results may vary.

    OKeeffesCompany.com

    ©2021 Distributed by:

    O'Keeffe's Company

    Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

  • PRINCIPAL DISPLAY PANEL

    O'KEEFFE'S

    MEDICATED

    LIP REPAIR

    LIP PROTECTANT | PETROLATUM

    + SEAL & HEAL

    RELIEVES EXTREMELY CRACKED, SPLIT LIPS

    GUARANTEED RELIEF

    Net Wt. 0.15 oz. (4.2 g)

    106903 SEAL & HEAL SINGLE

  • INGREDIENTS AND APPEARANCE
    OKEEFFES LIP REPAIR  SEAL AND HEAL
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71564-005-421 in 1 BLISTER PACK08/01/2021
    14.2 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:71564-005-842 in 1 BLISTER PACK08/01/2021
    24.2 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2021
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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