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

ZINC OXIDE 20.6%

MENTHOL 0.50%

PURPOSE

SKIN PROTECTANT

EXTERNAL ANALGESIC/ANTI-ITCH

INDICATIONS & USAGE

USES: AMOISTURE BARRIER THAT PREVENTS AND HELPS HEAL SKIN IRRITATIONS FROM: URINE, DIARRHEA, PERSPIRATION, FISTULA, 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: Cleanse skin with mild skin cleanser. Apply to affected area 2-4 times daily, or after each incontinent episode to promote comfort and long lasting protection.

INACTIVE INGREDIENT

Inactive Ingredients: Butyrospermum Parkii (Shea Butter), Cera Alba, Calamine, Cetearyl Alcohol, Chlorothymol, Cocos Nucifera(Coconut) Oil, Glyceryl Stearate and PEG 100 Stearate, Hydrogenated Polyisobutene, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mineral Oil, Petrolatum, Phenol, Phenoxyethanol (and) Benzoic Acid (and) Ethylhexyglycerin (and) Glycereth-2 Cocoate Propylene Glycol, Ricinus Communis (Castor) Seed Oil,Tapioca Starch (and) Polymethylsilsesquioxane Theobroma Cacao (Cocoa) Seed Butter, Thymol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERASEPTIN 
zinc oxide, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9204
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
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROTHYMOL (UNII: LJ25TI0CVT)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
LANOLIN (UNII: 7EV65EAW6H)
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOL (UNII: 339NCG44TV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9204-4	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/29/2012

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)