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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12090-0032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.5 mg  in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED20 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE180 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
EDETATE DISODIUM 
GLYCERIN 
LANOLIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLPARABEN 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-0032-35 g in 1 PACKET
2NDC:12090-0032-4113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/30/2009
Labeler - Summit Industries, Inc. (003279189)
Registrant - Summit Industries, Inc. (003279189)
Establishment
NameAddressID/FEIBusiness Operations
Summit Industries, Inc.003279189manufacture(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.