LANTISEPTIC SKIN PROTECTANT  - lanolin cream 
Summit Industries, Inc.

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Lantiseptic Skin Protectant

Active Ingredient Purpose

Lanolin USP 50 percent 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 degrees C (68-77 degrees 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

NDC 12090-0019-X

Lantiseptic

Used By Professionals

Skin Protectant

Skin barrier for incontinence

Diaper dermatitis

Chafed or ulcer prone skin

Net WT XXg (XXX oz)

LANTISEPTIC SKIN PROTECTANT  lanolin   cream

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (LANOLIN) LANOLIN 50 g  in 100 g

Inactive Ingredients Ingredient Name Strength WAX, YELLOW   EDETATE DISODIUM   MINERAL OIL   OXYQUINOLINE   PETROLATUM   WATER   SODIUM BORATE   SORBITAN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12090-0019-6 5 g In 1 PACKET None 2 12090-0019-1 14.2 g In 1 JAR None 3 12090-0019-2 70 g In 1 TUBE None 4 12090-0019-3 113 g In 1 JAR None 5 12090-0019-4 130 g In 1 JAR None 6 12090-0019-5 400 g In 1 JAR None

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	Operations
Summit Industries, Inc.		003279189	manufacture

Revised: 12/2009Summit Industries, Inc.