RxNorm Names

Review RxNorm Normal Forms

LANTISEPTIC MULTI-PURPOSE (menthol, calamine, zinc oxide) ointment
[Summit Industries, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4cc157aa-cdab-4ac2-bec4-647d26a4d7ee

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active Ingredients

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

External Analgesic, Skin Protectant

Uses

A moisture barrier that prevents and helps protect skin irritations from

urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage
minor burns
cuts
scrapes
itching

Warnings

For external use only.
When using this product
do not get into eyes.

Stop use and ask doctor if :

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, gently cleanse and dry area.

Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change.
Children under 12 years: Consult a doctor.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients:

Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions or Comments?

1-800-241-6996

SUMMIT INDUSTRIES, INC

PO Box 7329, Marietta, GA 30065

www.lantiseptic.com

Item # 0602

Image of representative container artwork

MultiPurposeSkinOintment5g.jpg Label 5g

LANTISEPTIC MULTI-PURPOSE
menthol, calamine, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12090-0032
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	4.5 mg in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED)	FERRIC OXIDE RED	20 mg in 1 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	180 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX
EDETATE DISODIUM
GLYCERIN
LANOLIN
METHYLPARABEN
MINERAL OIL
PETROLATUM
PROPYLPARABEN
WATER
SODIUM BORATE
SORBITAN SESQUIOLEATE

Packaging
#	Item Code	Package Description
1	NDC:12090-0032-3	5 g in 1 PACKET
2	NDC:12090-0032-4	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/30/2009

Labeler - Summit Industries, Inc. (003279189)

Registrant - Summit Industries, Inc. (003279189)

Establishment
Name	Address	ID/FEI	Business Operations
Summit Industries, Inc.		003279189	manufacture(12090-0032)

Revised: 01/2013

Document Id: cee1e77a-d865-40e7-9809-3f6438c59704

Set id: 4cc157aa-cdab-4ac2-bec4-647d26a4d7ee

Version: 3

Effective Time: 20130124

Summit Industries, Inc.

Daily Med

Current Medication Information

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