Label: LANOGUARD MULTI-PURPOSE- menthol, calamine, zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 12090-0061-0, 12090-0061-5 - Packager: Summit Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 21, 2013
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INGREDIENTS AND APPEARANCE
LANOGUARD MULTI-PURPOSE
menthol, calamine, zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-0061 Route of Administration TOPICAL 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:12090-0061-0 5 g in 1 PACKET 2 NDC:12090-0061-5 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/21/2013 Labeler - Summit Industries, Inc. (003279189) Establishment Name Address ID/FEI Business Operations Summit Industries, Inc. 003279189 manufacture(12090-0061)