VERASEPTINE MULTIPURPOSE MOISTURE BARRIER- zinc oxide cream

VeraSeptine Multipurpose Moisture Barrier by

Drug Labeling and Warnings

VeraSeptine Multipurpose Moisture Barrier by is a Otc medication manufactured, distributed, or labeled by LTC Products, Inc., Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 21%....Skin Protection

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

A moisture barrier that prevents and helps heal skin irritations from

• Urine
• diarrhea
• perspiration
• minor burns

WARNINGS

For external use only.

• Not for deep or puncture wounds
• Avoid contact with 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.

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.

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

Keep out of the reach of children. In case of accidental ingestion contact a physician or poison control center immediately

PRINCIPAL DISPLAY PANEL

61598-200-10.jpg

PRINCIPAL DISPLAY PANEL

  61598-200-00.jpg

PRINCIPAL DISPLAY PANEL

  61598-200-01.jpg

INGREDIENTS AND APPEARANCE

VERASEPTINE MULTIPURPOSE MOISTURE BARRIER 
zinc oxide cream

Product 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)