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Lantiseptic CaldaZinc

Dosage form: ointment
Ingredients: MENTHOL 4.5mg in 1g, ZINC OXIDE 180mg in 1g
Labeler: Santus LLC
NDC Code: 12090-0032

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:

LANTISEPTIC CALDAZINC 
menthol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-0032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.5 mg  in 1 g
ZINC OXIDE (ZINC CATION) ZINC CATION180 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
EDETATE DISODIUM 
GLYCERIN 
LANOLIN 
MINERAL OIL 
PETROLATUM 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage Description
1NDC:12090-0032-35 g in 1 PACKET
2NDC:12090-0032-4113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/02/2016
Labeler - Santus LLC (079868223)

 
Santus LLC

Medically reviewed on Jan 2, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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