Lantiseptic CaldaZinc Ointment

Lantiseptic CaldaZinc by

Drug Labeling and Warnings

Lantiseptic CaldaZinc by is a Otc medication manufactured, distributed, or labeled by Santus LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LANTISEPTIC CALDAZINC- menthol, zinc oxide ointment 
Santus LLC

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.

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Lantiseptic CaldaZinc Ointment

Active Ingredient

Menthol 0.45%

Zinc Oxide 18%

Purpose

External analgesic / Anti itch

Skin protectant / Anorectal astringent

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

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.

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.

Other Information

Store at 15-30°C (59-86°F).

Inactive Ingredients

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

Questions or Comments?

844-7SANTUS or visit www.lantiseptic.com

Package Labeling:

Ointment

LANTISEPTIC CALDAZINC 
menthol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 12090-0032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 12090-0032-35 g in 1 PACKET; Type 0: Not a Combination Product03/02/201612/12/2019
2NDC: 12090-0032-4113 g in 1 TUBE; Type 0: Not a Combination Product03/02/201612/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/02/201612/12/2019
Labeler - Santus LLC (079868223)

Revised: 1/2020
Document Id: 9d4b4ecc-8766-0bd3-e053-2a95a90a6d5a
Set id: 4cc157aa-cdab-4ac2-bec4-647d26a4d7ee
Version: 6
Effective Time: 20200129
 
Santus LLC