THERAZCREAM- triclosan cream

THERAZCREAM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.3%

PURPOSE

PURPOSE

ANTIBACTERIAL

INDICATIONS & USAGE

USE

TO DECREASE BACTERIA ON SKIN.

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USE

STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS: APPLY A SMALL AMOUNT OF CREAM TO THE SKIN AND RUB IN GENTLY.

INACTIVE INGREDIENT

INGREDIENTS

Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Alcohol Denat., Alkyl Benzoate, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Caprylic/Capric Triglycerides, Carbomer, Cetearyl Alcohol and Polysorbate 60, Cetyl Alcohol, Cetyl Alcohol (and) Glyceryl Stearate (and) PEG-75 Stearate (and) Ceteth-20 (and) Steareth-20, Diazolidinyl Urea, Dimethicone, Fragrance, Glycereth-26, Glycerin, Magnesium Aluminum Silicate, Mineral Oil, Ozokerite, Phenoxyethanol (and) Benzoic Acid (and) Ethylhexylglycerin (and) Glycereth-2 Cocoate, Polysorbate 20, Potassium Hydroxide, Retinyl Palmitate, Sodium Metabisulfite, Sorbic Acid, Steareth 2, Stearth-21, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E Acetate), Urea, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAZCREAM 
triclosan cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-75 STEARATE (UNII: OT38R0N74H)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBIC ACID (UNII: X045WJ989B)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9155-9	275 mL in 1 TUBE; Type 0: Not a Combination Product	04/17/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/17/2013

Labeler - Cal Pharma (078721283)