Label: SOOTHE AND COOL FREE MEDSEPTIC SKIN PROTECTANT- lanolin ointment

  • NDC Code(s): 53329-042-44, 53329-042-77
  • Packager: Medline Industries, LP
  • 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 21, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Lanolin, USP 50%

  • Purpose

    Skin protectant

  • Uses

    • helps to relieve minor skin irritations caused by wetness, urine and/or stool
    • temporarily protects chapped or cracked skin.
    • helps seal out wetness
  • Warnings

    For external use only

    When using this product

    • do not get into eyes
    • do not use on deep or puncture wounds, animal bites, and serious burns

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days, or clear upand occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control right away.

  • Directions

    • gently cleanse and dry affected area
    • apply liberally to affected area as needed.
  • Other information

  • Inactive ingredients

    8-hydroxyquinoline, aloe barbadensis leaf juice, beeswax, cholecalciferol, disodium EDTA, methylparaben, petrolatum, propylparaben, retinyl palmitate, sodium borate, sorbitan sesquioleate, tocopherol, water, zea mays (corn) oil

  • Manufacturing Information

    Manufactured for: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Manufactured in USA of domestic and foreign components

    www.medline.com

    1-800-MEDLINE

    REF: MSC095650

    RA17SFZ

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL FREE MEDSEPTIC  SKIN PROTECTANT
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-042-44113 g in 1 JAR; Type 0: Not a Combination Product01/01/2007
    2NDC:53329-042-7714 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!