Label: VERASEPTINE MULTIPURPOSE MOISTURE BARRIER- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61598-200-00, 61598-200-01, 61598-200-10 - Packager: LTC Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 28, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Petrolatum, Water, Mineral Oil, Glyceryl Stearate, Di-C12-15 Alkyl Fumarate, Glycerin, Dimethicone, Lanolin, Menthol, Phenol, Thymol, Chlorothymol, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Sunflower Oil, Isostearic Acid, Polyhydroxystearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Sodium Bicarbonate, Iron Oxide
- PURPOSE
- WARNINGS
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DOSAGE & ADMINISTRATION
Cleanse skin gently with mild skin cleanser, such as PeleVerus Wound Cleanser or Array Perineal Wash. Pat dry or allow to air dry. Apply a thin layer of VeraSeptine Moisture Barrier to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
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INDICATIONS & USAGE
A moisture barrier that prevents and helps heal skin irritations from urine, diarrhea, perspiration, minor burns, fistula drainage, feeding tube site leakage, wound drainage (peri-wound skin), cuts, scrapes, itching
Avoid contact with the eyes.
Keep out of the reach of children. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a physician.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERASEPTINE MULTIPURPOSE MOISTURE BARRIER
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61598-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LANOLIN (UNII: 7EV65EAW6H) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENOL (UNII: 339NCG44TV) THYMOL (UNII: 3J50XA376E) CHLOROTHYMOL (UNII: LJ25TI0CVT) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61598-200-10 100 g in 1 TUBE 2 NDC:61598-200-01 144 in 1 BOX 2 NDC:61598-200-00 3.5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/07/2013 Labeler - LTC Products, Inc. (967367991) Registrant - Kutol Products Company, Inc. (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company, Inc. 004236139 manufacture(61598-200) , analysis(61598-200) , label(61598-200) , pack(61598-200)
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