Label: SOOTHE AND COOL PROTECT- zinc oxide and white petrolatum paste

  • 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 11, 2019

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

View All Sections
  • Active ingredients

    White Petrolatum 50%

    Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • Uses

    ■ Temporarily relieves skin irritation including itching, burning, and discomfort

    ■ Temporarily forms a protective coating over inflamed tissues to help prevent drying

    ■ Protects minor skin irritation associated with diaper rash and helps seal out wetness

  • Warnings

    For external use only

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    • Do not get into the eyes

  • Stop use and ask a doctor if

    • Condition worsens or does not improve within 7 days
  • Keep out of reach of children

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

  • Directions

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

    Protect from freezing, avoid excessive heat.

  • Inactive ingredients

    Allantoin, Benzethonium Chloride, Eugenia Caryophyllus (Clove) Flower Oil, Zea Mays (Corn) Starch, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Xanthan Gum

  • SPL UNCLASSIFIED SECTION

    www.medline.com

    Manufactured in USA for Medline Industries, Inc.,

    Mundelein, IL 60060 USA.
    1-800-MEDLINE

  • PRINCIPAL DISPLAY PANEL

    NDC: 53329-004-10

    SOOTHE & COOL®

    PROTECT

    ZINC OXIDE

    SKIN PASTE

    • Provides a thick, protective barrier
    • Enhanced with vitamins A & E

    Net Wt. 2.5 oz (71 g)

    REF MSC095450

    label

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL PROTECT 
    zinc oxide and white petrolatum paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CLOVE OIL (UNII: 578389D6D0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-004-0271 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 finalpart34601/01/2007
    Labeler - Medline Industries, Inc. (025460908)
    Registrant - Dhaliwal Labs Illinois, Llc (079679410)
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!