Label: SOOTHE AND COOL MOISTURE GUARD- white petrolatum paste

  • NDC Code(s): 53329-303-22
  • 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 July 14, 2023

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  • Active ingredient

    Petrolatum 59%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor cuts, scrapes, and burns
    • Temporarily protects and helps relieve chapped or cracked skin
    • 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 eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few 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 as needed
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Aluminum Stearates, Beeswax, Benzethonium Chloride, Chloroxylenol, Cholecalciferol, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate, Sorbitan Sesquioleate, Stearic Acid, Tocopherol, Water, Zea Mays (Corn) Oil, Zinc Oxide

  • SPL UNCLASSIFIED SECTION

    REF MSC954435

    www.medline.com

    Manufactured for Medline Industries, Inc.

    Mundelein, IL 60060 USA. 1-800-MEDLINE

    RL15UPK

  • Package Label

    Label 303

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL MOISTURE GUARD 
    white petrolatum paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STEARATES (UNII: O4D7U3B46U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-303-2299 g in 1 TUBE; Type 0: Not a Combination Product11/06/201305/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01611/06/201305/31/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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