Z-GUARD (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES INC.]

Z-GUARD (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES INC.]
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NDC 53329-137-14, 53329-137-16, 53329-137-44, 53329-137-96
Set ID 2b70b8c7-d6d5-4bd3-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Medline Industries Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • Active ingredient

    White Petrolatum 57%

    Zinc Oxide 17%

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  • Purpose

    Skin Protectant

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  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin
    • Temporarily protects minor cuts, scrapes, and burns
    • Protects minor skin irritation associated with diaper rash and helps seal out wetness
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  • 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.

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  • Directions

    • For skin protection
    • Apply as needed
    • For diaper rash
    • Change wet and soiled diapers promptly
    • Cleanse area and allow to dry
    • Apply as needed with each diaper change.
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  • Other information

    • Protect from freezing. Avoid excessive heat.
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  • Inactive ingredients

    7-dehydrocholestrol, aphanizomemnon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, cocos nucifera (coconut) oil, corn starch, dimethicone, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, isopropyl myristate, manuka honey, methyldihydrojasmonate, olea europaea (olive) fruit oil, paraffin wax, phospholipids, tocopherol acetate, vanilla planifolia fruit extract, water, yeast ferment extract, zea mays (corn) oil

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  • SPL UNCLASSIFIED SECTION

    Phytoplex, Medline Remedy, Medline and Z-Guard are
    registered trademarks of Medline Industries, Inc. Manufactured
    for: Medline Industries, Inc., Mundelein, IL 60060 USA. Made
    in USA. www.medline.com 1-800-MEDLINE

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  • Package/Label Principal Display Panel

    NDC 53329-137-44

    Medline

    REMEDY®

    PHYTOPLEX®

    Botanical Nutrition for Sensitive Skin

    Protectant

    Z-Guard® Paste

    Helps relieve symptoms associated with prolonged exposure to moisture

    CHG Compatible

    Paraben Free

    Hypoallergenic

    Pediatrician Tested

    For All Ages

    Net Wt. 4 oz (113 g)

    label

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  • INGREDIENTS AND APPEARANCE
    Z-GUARD 
    white petrolatum,zinc oxide paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-137
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 57 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    CLOVE (UNII: K48IKT5321)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    YEAST (UNII: 3NY3SM6B8U)  
    VANILLA (UNII: Q74T35078H)  
    HONEY (UNII: Y9H1V576FH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-137-14 57 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:53329-137-44 113 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:53329-137-96 144 in 1 BOX
    3 NDC:53329-137-16 5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/06/2016
    Labeler - Medline Industries Inc. (025460908)
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