Label: LANTISEPTIC CALDAZINC- menthol, zinc oxide ointment

  • NDC Code(s): 12090-0032-3, 12090-0032-4
  • Packager: Santus LLC
  • 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 March 4, 2016

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

  • Active Ingredient

    Menthol 0.45%

    Zinc Oxide 18%

    Purpose

    External analgesic / Anti itch

    Skin protectant / Anorectal astringent

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  • Uses

    A moisture barrier that prevents and helps heal skin irritation from: •urine • diarrhea • perspiration • fistula damage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching

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  • Warnings

       • For external use only •Not for deep or puncture wounds • Avoid contact with eyes

    Keep out of reach of children

    • In case of accidental ingestion contact a physician or poison control center immediately • If condition worsens or does not improve within 7 days, consult a doctor.

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  • Directions

    Gently cleanse skin with mild cleanser. Pat dry or allow to air dry. Apply a thin layer of CaldaZinc Ointment to affected area 2-4 times daily or after each incontinent episode or diaper change to promote relief and long-lasting protection.

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  • Other Information

    Store at 15-30°C (59-86°F).

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  • Inactive Ingredients

    Beeswax, Calamine, Disodium EDTA, DMDM Hydantoin + IPBC, Glycerin, Lanolin, Mineral Oil, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate.

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  • Questions or Comments?

    844-7SANTUS or visit www.lantiseptic.com

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC CALDAZINC 
    menthol, zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-0032
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.5 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 180 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-0032-3 5 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:12090-0032-4 113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/02/2016
    Labeler - Santus LLC (079868223)
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