Label: REPARA- lanolin ointment

  • 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 August 7, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    Lanolin USP 50% .................. Skin Protectant

  • PURPOSE

    Repara Advanced Skincare

    Skin Protectant w/ Lanolin

    Multi-Purpose

    • Contains 50% Lanolin USP
    • Skin Barrier for Incontinence Diaper Rash
    • Protects chafed or ulcer prone skin

    Light Scent

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Gently cleanse and dry area.
    • Apply liberally to affected area as needed.
  • WARNINGS

    Warnings

    • For external use only
    • When using this product
    • do not get into eyes.
    • Do not apply to deep or puncture wounds.
    • 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.
  • INDICATIONS & USAGE

    Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.

    Precautions: FOR EXTERNAL USE ONLY. Discontinue use should irritation occur. Do not use on deep puncture wounds, animal bites, and serious burns.

    Frequency: Daily.

    Uses

    • Helps prevent diaper dermatitis.
    • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    beeswax (yellow wax), fragrance, HEEDTA, lanolin alcohol, mineral oil, oxyquinolone, petrolatum, purified water, sodium borate, sorbitan sesquioleate.

  • OTHER SAFETY INFORMATION

    Manufactured for PSS World Medical, Inc.

    4345 Southpoint Blvd., Jacksonville, FL 32216

    Comments or Questions? 800-777-4908

    Made in the USA

    Other Information

    Store at 20oC - 25oC (68oF - 77oF).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    REPARA 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-818(NDC:12090-0019)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN5 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID (UNII: R79J91U341)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-818-25144 in 1 CARTON
    15 g in 1 PACKAGE
    2NDC:68345-818-26114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2014
    Labeler - PSS World Medical, Inc. (101822682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summit Industries Inc.003279189manufacture(68345-818)
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