Drug Labeling and Warnings

Drug Details

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THERAZCREAM- triclosan cream 
Cal Pharma

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.

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TRICLOSAN 0.3%

PURPOSE

ANTIBACTERIAL

USE

TO DECREASE BACTERIA ON SKIN.

WARNINGS

FOR EXTERNAL USE ONLY

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

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

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

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

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

TheraZcream_ARTWORK

THERAZCREAM 
triclosan cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-9155
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-9155-9275 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2013
Labeler - Cal Pharma (078721283)

Revised: 4/2013
 
Cal Pharma


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