LANTISEPTIC MULTI-PURPOSE SKIN OINTMENT  - menthol and zinc oxide ointment 
Summit Industries, Inc.

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Lantiseptic Multi-Purpose Skin Ointment

Active Ingredients                                        Purpose

Menthol 0.45 percent                                    External Analgesic

Zinc Oxide 20 percent                                   Skin Protectant / Anorectal (Hemorroidal)

Uses

A multi-purpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower

abdomen and inner thighs due to moisture, occlusion, chafing or continued contact with urine or feces. Helps relieve

local discomfort, burning and itching in the perianal area related to anorectal disorders and hemorrhoids.

Temporarily relieves pain and itching due to  minor burns, minor cuts, scrapes, insect bites, sunburn, minor skin irritations.

Dries oozing and weeping of poison: ivy, oak, sumac.

Warnings

For external use only.

When using this product avoid contact with 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

Do not exceed recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.

Do not put product into rectum by using fingers or any mechanical device or applicator.

Certain persons can develop allergic reactions to this product.
If the symptom being treated does not subside or if redness, irritation, swelling pain or other symptoms
develop or increase, discontinue use and consult a doctor.
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 degrees C (59-86 degrees F)

Inactive Ingredients:

Beeswax, Calamine, Disodium ESTA, Glycerin, Lanolin, Methylparaben,

Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions or Comments?

1-80-241-6996

SUMMIT INDUSTRIES, INC

PO Box 7329, Marietta, GA 30065

www.lantiseptic.com

NDC 12090-0032-X

Lantiseptic

Multi-Purpose Skin Ointment

Temporarily Protects Irritated Skin Due To:

Incontinence, Diaper Rash, Chafing

Temporarily Relieves Itching

External Analgesic
Skin Protectant

Net WT Xg (XXX oz)

LANTISEPTIC MULTI-PURPOSE SKIN OINTMENT  menthol, zinc oxide   ointment

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.45 g  in 100 g ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 g  in 100 g

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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12090-0032-3 5 g In 1 PACKET None 2 12090-0032-4 113 g In 1 TUBE None

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	Operations
Summit Industries, Inc.		003279189	manufacture

Revised: 12/2009Summit Industries, Inc.