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.

----------

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12090-0032-3	5 g in 1 PACKET; Type 0: Not a Combination Product	03/02/2016	12/12/2019
2	NDC:12090-0032-4	113 g in 1 TUBE; Type 0: Not a Combination Product	03/02/2016	12/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	03/02/2016	12/12/2019

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