THERASEPTIN- zinc oxide menthol ointment

THERASEPTIN by

Drug Labeling and Warnings

THERASEPTIN by is a Otc medication manufactured, distributed, or labeled by Cal Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

METHYL SALICYLATE (28%)

MENTHOL (10%)

CAPSAICIN (0.25%)

PURPOSE

TOPICAL ANALGESIC

INDICATIONS & USAGE

Uses: A moisture barrier that prevents & helps heal skin irritations from: urine, diarrhea, perspiration, stula, drainage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY

Avoid contact with eyes. In case of contact, flush thoroughly with warm water

Not for use on deep or puncture wounds.

STOP USE

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: In case of accidental ingestion contact a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION

DIRECTIONS

- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

INACTIVE INGREDIENT

Inactive Ingredients: Calamine, Chlorothymol, Glycerin, Lanolin, Methylparaben, Petrolatum, Phenol, Propylparaben, Sodium Bicarbonate, Thymol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERASEPTIN 
zinc oxide menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CHLOROTHYMOL (UNII: LJ25TI0CVT)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOL (UNII: 339NCG44TV)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9109-4	120 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/29/2012

Labeler - Cal Pharma (078721283)