RxNorm Names

Review RxNorm Normal Forms

LANTISEPTIC SKIN PROTECTANT (lanolin) cream
[Summit Industries, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=daefbb0e-7650-4f35-b337-14a10f869ae2

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not 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 Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

Helps prevent and treat diaper dermatitis.
Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Warnings

For external use only.
Avoid contact with eyes.
Do not apply to deep or puncture wounds.
If condition worsens, or does not improve within 7 days, consult a doctor.
If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Gently cleanse and dry area.
Apply liberally to affected area as needed.

Other information

Store at 20-25°C (68-77°F)

Inactive ingredients

Beeswax (yellow wax), Fragrance, HEEDTA, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

If you have questions or comments, call

800-241-6996 or visit

www.Lantiseptic.com

SUMMIT INDUSTRIES, INC

Lantiseptic Division

PO BOX 7329

Marietta, GA 30065

Image of representative container

SP400g.jpg Skin Protectant Label 400 grams

SP_130.jpg image description

LANTISEPTIC SKIN PROTECTANT
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12090-0019
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (LANOLIN)	LANOLIN	500 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID
LANOLIN ALCOHOLS
MINERAL OIL
OXYQUINOLINE
PETROLATUM
WATER
SODIUM BORATE
SORBITAN SESQUIOLEATE

Packaging
#	Item Code	Package Description
1	NDC:12090-0019-6	5 g in 1 PACKET
2	NDC:12090-0019-1	14.2 g in 1 JAR
3	NDC:12090-0019-2	70 g in 1 TUBE
4	NDC:12090-0019-3	113 g in 1 JAR
5	NDC:12090-0019-4	130 g in 1 JAR
6	NDC:12090-0019-5	400 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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(12090-0019)

Revised: 01/2013

Document Id: a25a6658-8dc8-4493-93bf-85aeff479299

Set id: daefbb0e-7650-4f35-b337-14a10f869ae2

Version: 2

Effective Time: 20130121

Summit Industries, Inc.

Daily Med

Current Medication Information

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