Label: SKIN PROTECTANT WITH LANOLIN- lanolin cream

  • NDC Code(s): 68599-6203-1, 68599-6203-4
  • Packager: McKesson
  • 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 14, 2021

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  • ACTIVE INGREDIENT

    Lanolin 50%

  • PURPOSE

    Purpose: Skin protectant

  • INDICATIONS & USAGE

    Uses

    • Helps prevent skin irritations
    • Protects chafed skin or minor skin irritations due to incontinence
  • WARNINGS

    Warnings
    For external use only.

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition lasts more than 7 days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • 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.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Beeswax (Yellow Wax), Disodium EDTA, DMDM Hydantoin, Lanolin Alcohol, Mineral Oil, Petrolatum, Sodium Borate, Sorbitan Sesquioleate, Water

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-6203-1

    McKesson

    Skin Protectant Cream

    WITH LANOLIN

    MULTI-PURPOSE | PARABEN FREE
    FRAGRANCE FREE

    Protects chafed skin or minor skin irritation;
    helps prevent diaper dermatitis.


    NET Weight

    4 oz

    (133 g)

    MFR # 4615

    4615 each4615 case

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT WITH LANOLIN 
    lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-6203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-6203-424 in 1 CASE10/04/2017
    1NDC:68599-6203-1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/04/2017
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTec785961046manufacture(68599-6203)
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