Label: REMEDY CALAZIME SKIN PROTECTANT- calamine, menthol, white petrolatum, zinc oxide paste

  • NDC Code(s): 53329-165-02, 53329-165-44, 53329-165-96
  • 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 August 8, 2023

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  • Active ingredient

    Calamine 3.5%

    Menthol 0.2%

    White Petrolatum 69%

    Zinc Oxide 16.5%

  • Purpose

    Protectant

    Protectant

    Prot

    Protectant

  • Uses

    • Provides temporary relief from skin irritations, itching and discomfort in the perianal area
    • For the temporary relief of pain
    • May provide a cooling sensation
  • Warnings

    For External Use Only

    Do not use

    • in the eyes
    • on deep or puncture wounds
    • on animal bites
    • on serious burns.

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, stop use and consult a doctor

    Stop use and ask a doctor if

    • condition worsens or does not improved within 7 days
    • you experience bleeding

    Keep out of reach of children.

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

    Adults

    • Cleanse the affected area with Remedy No-rinse cleanser
    • Gently dry
    • Apply externally to the affected area up to 6 times daily
    • For peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed.

    Children under 12 years of age

    • Consult a doctor
  • Other information

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

    Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, Zea Mays (Corn) Oil.

  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc.
    Olivamine is a registered trademark of McCord Research, Inc. Manufactured for
    Medline Industries, Inc., Mundelein, IL 60060 www.medline.com
    1-800-MEDLINE

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    REMEDY CALAZIME SKIN PROTECTANT 
    calamine, menthol, white petrolatum, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM69 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    GLYCINE (UNII: TE7660XO1C)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROXYTYROSOL (UNII: QEU0NE4O90)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    VANILLIN (UNII: CHI530446X)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-165-44113 g in 1 TUBE; Type 0: Not a Combination Product03/14/201803/21/2024
    2NDC:53329-165-96144 in 1 BOX03/14/201812/13/2023
    24 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-165-023 in 1 BAG07/01/2021
    3NDC:53329-165-44113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/23/2012
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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