Label: MEDLINE REMEDY PHYTOPLEX CALAZIME- menthol, zinc oxide, petrolatum paste

  • NDC Code(s): 53329-105-14, 53329-105-44, 53329-105-87, 53329-105-96
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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  • Active Ingredients

    • Menthol 0.44%
    • White Petrolatum 53%
    • Zinc Oxide 20.6%
  • Purpose

    • External Analgesic, Anti-itch
    • Protectant
    • Protectant
  • Uses

    • for the temporary relief of local itching and discomfort in the perianal area
    • temporarily protects irritated areas
    • for the temporary relief of pain
    • may provide a cooling sensation
  • Warnings

    • For external use only
    • Avoid contact with eyes

    When using this product

    • do not place into the rectum with fingers or any device or applicator
    • keep out of reach of children

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • bleeding occurs
    • an allergic reaction develops with symptoms such as redness, irritation, or pain

    Keep out of reach of children.

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

    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
  • Directions

    • adults: Cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth. Apply product externally to the affected area up to 6 times daily.
    • children under 12 years of age: consult a doctor
  • Inactive ingredients

    7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, corn starch, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.

  • Other information

    Protect from freezing. Avoid excessive heat.

  • Manufacturing Information

    Manufactured for Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    www.medline.com

    1-800-MEDLINE

    REF: MSC092554

    RH19PUA

  • Package Labels

    Label 14

    packet

    box

    Label 44

  • INGREDIENTS AND APPEARANCE
    MEDLINE REMEDY PHYTOPLEX CALAZIME 
    menthol, zinc oxide, petrolatum paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL44 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PHYTONADIONE (UNII: A034SE7857)  
    YEAST (UNII: 3NY3SM6B8U)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NORI (UNII: 477TV3P5UX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    HONEY (UNII: Y9H1V576FH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-105-44113 g in 1 TUBE; Type 0: Not a Combination Product07/09/201811/30/2025
    2NDC:53329-105-96144 in 1 CARTON07/09/201812/31/2024
    2NDC:53329-105-874 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-105-1457 g in 1 TUBE; Type 0: Not a Combination Product07/09/201805/31/2025
    4NDC:53329-105-874 g in 1 PACKET; Type 0: Not a Combination Product07/09/201812/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/09/201811/30/2025
    Labeler - Medline Industries, LP (025460908)
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