Your browser does not support JavaScript! LANTISEPTIC MULTI-PURPOSE (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [SUMMIT INDUSTRIES, INC.]
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LANTISEPTIC MULTI-PURPOSE (menthol, calamine, zinc oxide) ointment
[Summit Industries, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

  • For external use only.
  • When using this product
  • do not get into eyes.

Stop use and ask doctor if :

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, gently cleanse and dry area.

  • Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change.
  • Children under 12 years: Consult a doctor.

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
 
Summit Industries, Inc.

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