LANTISEPTIC SKIN PROTECTANT- 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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Lantiseptic Skin Protectant Drug Facts

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

Warnings

Directions

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.jpgSkin 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 (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 500 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 1/2013
Document Id: a25a6658-8dc8-4493-93bf-85aeff479299
Set id: daefbb0e-7650-4f35-b337-14a10f869ae2
Version: 2
Effective Time: 20130121
 
Summit Industries, Inc.