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 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)

Revised: 3/2016
Document Id: 2d3fd7bb-44f7-1429-e054-00144ff8d46c
Set id: 4cc157aa-cdab-4ac2-bec4-647d26a4d7ee
Version: 4
Effective Time: 20160304
 
Santus LLC