LANTISEPTIC MULTI-PURPOSE- menthol, ferric oxide red and zinc oxide 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 Multi-Purpose Skin Ointment Drug Facts

Active Ingredients

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

External Analgesic, Skin Protectant

Uses

A moisture barrier that prevents and helps protect skin irritations from

Warnings

Stop use and ask doctor if :

Directions

When practical, gently cleanse and dry area.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients:

Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions or Comments?

1-800-241-6996

SUMMIT INDUSTRIES, INC

PO Box 7329, Marietta, GA 30065

www.lantiseptic.com

Item # 0602

Image of representative container artwork

MultiPurposeSkinOintment5g.jpgLabel 5g

LANTISEPTIC  MULTI-PURPOSE
menthol, calamine, zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-0032
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.5 mg  in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 180 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12090-0032-3 5 g in 1 PACKET
2 NDC:12090-0032-4 113 g in 1 TUBE
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 Business Operations
Summit Industries, Inc. 003279189 manufacture(12090-0032)

Revised: 1/2013
Document Id: cee1e77a-d865-40e7-9809-3f6438c59704
Set id: 4cc157aa-cdab-4ac2-bec4-647d26a4d7ee
Version: 3
Effective Time: 20130124
 
Summit Industries, Inc.