LANTISEPTIC DAILY CARE SKIN PROTECTANT- lanolin ointment 
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 Daily Care Skin Protectant Drug Facts

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

Warnings

Directions

Other Information

Store at 20-25°C (68-77°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

Images of representative container artwork

4oz.jpgLabel lantiseptic_multipack.jpgMultipack

LANTISEPTIC  DAILY CARE SKIN PROTECTANT
lanolin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-0040
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 300 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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:12090-0040-1 5 g in 1 PACKET
2 NDC:12090-0040-8 6 in 1 BOX
2 NDC:12090-0040-2 14.2 g in 1 PACKET
3 NDC:12090-0040-3 70 g in 1 JAR
4 NDC:12090-0040-4 113 g in 1 TUBE
5 NDC:12090-0040-5 130 g in 1 JAR
6 NDC:12090-0040-6 227 g in 1 JAR
7 NDC:12090-0040-7 400 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(12090-0040)

Revised: 1/2013
Document Id: 93a317f8-b434-446f-922e-cfd69c7680a5
Set id: 0fb56eed-66b6-4aa8-80b4-67015b99cd08
Version: 8
Effective Time: 20130121
 
Summit Industries, Inc.