Label: PRIMAGUARD DAILY CARE SKIN PROTECTANT- 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 March 21, 2013

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

View All Sections
  • Active Ingredient

    Lanolin USP 30%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and treat skin irritations.
    • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.
  • Warnings: FOR EXTERNAL USE ONLY

    • Avoid contact with eyes.
    • Do not apply to deep or puncture wounds.
    • If condition worsens, or does not improve within 7 days, consult a doctor.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

    • KEEP OUT OF REACH OF CHILDREN.
  • Directions

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

  • Other Information

    Store at 20-25°C (68-77°F)

  • Inactive ingredients:

    Beeswax (yellow wax), Disodium EDTA, Fragrance, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

  • QUESTIONS

    Questions or comments?

    Call 800-809-4556

    or visit www.fcms

    First Choice Medical Supply

    127 Interstate Dr.

    Richland, MS 39218

  • Images of representative container artwork

    PrimaGuardProtectTubeLabel.jpgTube

  • INGREDIENTS AND APPEARANCE
    PRIMAGUARD  DAILY CARE SKIN PROTECTANT
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75904-3343
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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:75904-3343-45 g in 1 POUCH
    2NDC:75904-3343-5113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/28/2011
    Labeler - First Choice Medical Supply (117734405)
    Registrant - Summit Industries, Inc. (003279189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summit Industries, Inc.003279189manufacture(75904-3343)
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!