LANOGUARD DRY SKIN THERAPY- lanolin cream
Summit Industries, Inc.

Disclaimer: 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.

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LanoGuard Dry Skin Therapy Therapeutic Cream Drug Facts

Active Ingredient

Lanolin USP 37%

Purpose

Skin Protectant

Uses

Helps protect ulcer prone skin.
For treatment of cracked skin, minor burns or irritation.
Helps prevent chafing and dryness.

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.
Massage liberally into affected area as needed.
Cover treated feet.

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

Questions Comments?

1-800-241-6996 or www.lantiseptic.com

SUMMIT INDUSTRIES, INC

Lantiseptic Division

PO BOX 7329

Marietta, GA 30065

Image of representative artwork

LanoGuardDrySkinfouroz.jpg Label

LANOGUARD DRY SKIN THERAPY
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12090-0042
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	370 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID (UNII: R79J91U341)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
OXYQUINOLINE (UNII: 5UTX5635HP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12090-0042-5	113 g in 1 TUBE

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

Labeler - Summit Industries, Inc. (003279189)

Name	Address	ID/FEI	Business Operations
Establishment
Summit Industries, Inc.		003279189	manufacture(12090-0042)