THERAZCREAM

Manufacturer: Cal Pharma
Effective date: 2019-11-23
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:57:35

Label at a glance#

ProductTHERAZCREAM

Active ingredientTRICLOSAN

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

TRICLOSAN 0.3%

OTC - PURPOSE SECTION

PURPOSE

ANTIBACTERIAL

INDICATIONS & USAGE SECTION

USE

TO DECREASE BACTERIA ON SKIN.

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TheraZcream_ARTWORK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55628-9155-9	2024-04-01	C162847	48780-1	d6a99b39-b98d-a426-e053-dadaa90af4c2	87812549-30ab-400d-a0e9-0ec00121d1ca
55628-9155-9	2022-01-28	C162847	48780-1	d6a99b39-b98d-a426-e053-dadaa90af4c2	87812549-30ab-400d-a0e9-0ec00121d1ca

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
GLYCERETH-2 COCOATE	INACTIVE INGREDIENT	JWM00VS7HC	1
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PEG-75 STEARATE	INACTIVE INGREDIENT	OT38R0N74H	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	1
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

THERAZCREAM
TRICLOSAN
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
ALCOHOL
ALKYL (C12-15) BENZOATE
ALOE VERA LEAF
BENZYL ALCOHOL
SHEA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER 940
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-75 STEARATE
CETETH-20
STEARETH-20
DIAZOLIDINYL UREA
DIMETHICONE
GLYCERETH-26
GLYCERIN
MAGNESIUM ALUMINUM SILICATE
MINERAL OIL
CERESIN
PHENOXYETHANOL
BENZOIC ACID
ETHYLHEXYLGLYCERIN
GLYCERETH-2 COCOATE
POLYSORBATE 20
POTASSIUM HYDROXIDE
VITAMIN A PALMITATE
SODIUM METABISULFITE
SORBIC ACID
STEARETH-21
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
UREA
WATER
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55628-9155	55628-9155-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TRICLOSAN	4NM5039Y5X	ACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	IACT
ALCOHOL	3K9958V90M	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
SHEA BUTTER	K49155WL9Y	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
CARBOMER 940	4Q93RCW27E	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-75 STEARATE	OT38R0N74H	IACT
CETETH-20	I835H2IHHX	IACT
STEARETH-20	L0Q8IK9E08	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERETH-26	NNE56F2N14	IACT
GLYCERIN	PDC6A3C0OX	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
MINERAL OIL	T5L8T28FGP	IACT
CERESIN	Q1LS2UJO3A	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLYCERETH-2 COCOATE	JWM00VS7HC	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SORBIC ACID	X045WJ989B	IACT
STEARETH-21	53J3F32P58	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
UREA	8W8T17847W	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 486 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	990.3 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOAP / TOPICAL	0.36 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET, CHEWABLE / ORAL	0.2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBCUTANEOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / RECTAL	2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRA-ARTICULAR	0.2 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, COATED / ORAL	0.02 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INTRAVENOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
STEARETH-20	STEARETH-20	L0Q8IK9E08	CREAM / TOPICAL	4.15 %w/w		Exact identifier — unii candidate
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CREAM / TOPICAL		3300 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / ENDOTRACHEAL		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
150e1036-ccb2-b2f0-e063-6294a90a5bfe			87812549-30ab-400d-a0e9-0ec00121d1ca	2024-04-01	Warnings	Exact identifier spl set id: 87812549-30ab-400d-a0e9-0ec00121d1ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.