LANTISEPTIC DAILY CARE SKIN PROTECTANT  - lanolin ointment 
Summit Industries, Inc.

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Lantiseptic Daily Care Skin Protectant

Active Ingredient                  Purpose  

Lanolin USP 30 percent       Skin Protectant

  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.

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), Disodium EDTA, Fragrance, 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 12090-0040-X

Lantiseptic Daily Care Skin Protectant

Moisturizer and Protectant

Helps treat skin tears and cracks, chafed or irritated skin, and minor burns. Moisturize and protect severely dry or ulcer-prone skin.

Net WT XXg  (XXX oz)

Recommended to use daily for
Preventing skin tears and cracks
Chafing
Fecal and urinary incontinence skin irritations
Reddened, ulcer-prone skin
Diabetic skin irritations
Dry cracked heels
Feet with fissures
Foot Calluses


Protect and moisturize in one easy step.
Lantiseptic Daily Care Skin Protectant helps prevent and treat skin irritations caused by incontinence associated dermatitis and ulcer-prone or chafed skin. This unique 30% lanolin formulation penetrates deep into the skin and provides strong moisture barrier protection.

LANTISEPTIC DAILY CARE SKIN PROTECTANT  lanolin   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 12090-0040 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (LANOLIN) LANOLIN 30 g  in 100 g

Inactive Ingredients Ingredient Name Strength YELLOW WAX   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 12090-0040-1 5 g In 1 PACKET None 2 12090-0040-2 14.2 g In 1 PACKET None 3 12090-0040-3 70 g In 1 JAR None 4 12090-0040-4 113 g In 1 TUBE None 5 12090-0040-5 130 g In 1 JAR None 6 12090-0040-6 227 g In 1 JAR None 7 12090-0040-7 400 g In 1 JAR None 8 12090-0040-8 6 PACKET In 1 BOX contains a PACKET 8 14.2 g In 1 PACKET This package is contained within the BOX (12090-0040-8)

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: 12/2010Summit Industries, Inc.