Miracle Worker SPF 55

Manufacturer: Philosophy, Inc | AMCOL Health and Beauty Solutions, Inc.
Effective date: 2011-01-24
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:27:21

Label at a glance#

ProductMiracle Worker SPF 55

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE (3.00%)........SUNSCREEN

HOMOSALATE (10.00%)......SUNSCREEN

OCTISALATE (5.00%)...........SUNSCREEN

OCTOCRYLENE (2.00%).......SUNSCREEN

OXYBENZONE (6.00%).........SUNSCREEN

OTC - PURPOSE SECTION

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE PROTECTION

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

OTC - ASK DOCTOR SECTION

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

APPLY LIBERALLY TO CLEAN, DRY FACE IN THE MORNING BEFORE SUN EXPOSURE AND AS NEEDED. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

INACTIVE INGREDIENT SECTION

WATER (AQUA), BUTYLENE GLYCOL, PEG-8, POLYETHYLENE, DIMETHICONE, TETRAPEPTIDE-21, HEXYLDECANOL, PICEA EXCELSA WOOD EXTRACT, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, ALOE BARBADENSIS LEAF JUICE, SODIUM ASCORBYL PHOSPHATE, CETYLHYDROXYPROLINE PALMITAMIDE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, GLYCERIN, BISABOLOL, TOCOPHEROL, RETINYL PALMITATE, TOCOPHERYL ACETATE, SODIUM POLYACRYLATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, LAURYL GLUCOSIDE, TITANIUM DIOXIDE, BENTONITE, STEARIC ACID, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, CHLORPHENESIN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1Enter section text here

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50184-6500-1	2019-10-29	C162847	48780-1	960f7f55-d361-8e05-e053-dbdaa90a074a	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50184-6500-1	Miracle Worker SPF 55	50 mL in 1 TUBE	CREAM	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50184-6500	MIRACLE WORKER SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) CREAM [PHILOSOPHY, INC]	3	Legacy NDC, 1 package rows	20110301_be86026f-50ec-4f87-92a8-f62513816b73.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	3
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	3
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	3
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	3
BRASSICA RAPA VAR. RAPA	INACTIVE INGREDIENT	AIV6895O8B	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	INACTIVE INGREDIENT	59TL3WG5CO	3
CETYLHYDROXYPROLINE PALMITAMIDE	INACTIVE INGREDIENT	74ONU0S62G	3
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HEXYLDECANOL	INACTIVE INGREDIENT	151Z7P1317	3
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	3
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
PICEA ABIES WOOD	INACTIVE INGREDIENT	72GZ8K8996	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	3
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	3
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	3
TETRAPEPTIDE-21	INACTIVE INGREDIENT	179JUC43HU	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	3

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

Miracle Worker SPF 55
avobenzone, homosalate, octisalate, octocrylene and oxybenzone
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE
OXYBENZONE
WATER
BUTYLENE GLYCOL
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL
DIMETHICONE
HEXYLDECANOL
BRASSICA RAPA VAR. RAPA
ALOE VERA LEAF
SODIUM ASCORBYL PHOSPHATE
WHEAT GERM
GLYCERIN
LEVOMENOL
ALPHA-TOCOPHEROL
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE, D-
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
LAURYL GLUCOSIDE
TITANIUM DIOXIDE
BENTONITE
STEARIC ACID
EDETATE DISODIUM
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
CHLORPHENESIN
TETRAPEPTIDE-21
PICEA ABIES WOOD
CETYLHYDROXYPROLINE PALMITAMIDE
SODIUM POLYACRYLATE (8000 MW)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50184-6500	50184-6500-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
WATER	059QF0KO0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
DIMETHICONE	92RU3N3Y1O	IACT
HEXYLDECANOL	151Z7P1317	IACT
BRASSICA RAPA VAR. RAPA	AIV6895O8B	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SODIUM ASCORBYL PHOSPHATE	836SJG51DR	IACT
WHEAT GERM	YR3G369F5A	IACT
GLYCERIN	PDC6A3C0OX	IACT
LEVOMENOL	24WE03BX2T	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	59TL3WG5CO	IACT
LAURYL GLUCOSIDE	76LN7P7UCU	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
BENTONITE	A3N5ZCN45C	IACT
STEARIC ACID	4ELV7Z65AP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
TETRAPEPTIDE-21	179JUC43HU	IACT
PICEA ABIES WOOD	72GZ8K8996	IACT
CETYLHYDROXYPROLINE PALMITAMIDE	74ONU0S62G	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	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 5 · 283 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER, DENTIFRICE / DENTAL	0.05 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 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
46163b03-b532-4d5d-99f1-c9d024800086			be86026f-50ec-4f87-92a8-f62513816b73	2011-01-24	Warnings	Exact identifier spl id: 46163b03-b532-4d5d-99f1-c9d024800086 spl set id: be86026f-50ec-4f87-92a8-f62513816b73

Reported adverse events (FAERS/openFDA)#

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