FDA.reportPublic FDA data

Blistex Enhancement Series (Deep Renewal and Silk and Shine)

Manufacturer
Blistex Inc.
Effective date
2014-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:34

Label at a glance#

ProductBlistex Enhancement Series (Deep Renewal and Silk and Shine)
Active ingredientDimethicone, Octinoxate, Oxybenzone, Avobenzone, Octocrylene
Label structure15 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially ...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DEEP RENEWAL®

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0% (w/w)Sunscreen
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Octocrylene 2.7% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

SPL UNCLASSIFIED SECTION

SILK & SHINE®

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, flavors, hydrogenated polyisobutene, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, PPG-5-Ceteth-20, saccharin, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9865-1

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

VALUE PACK
Anti-aging rejuvenation
Satiny smooth & light shine

BROAD SPECTRUM SPF 15

2 Sticks Net Wt. 0.13 oz. (3.69 g) Ea.

SPF 15

Principal Display Panel - Kit Blister Pack
Principal Display Panel - Kit Blister Pack

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-9865-12020-01-31C16284748780-19d75b9d0-3a48-f424-e053-dadaa90a57ceBlistex ® Enhancement Series ® (Deep Renewal ® and Silk & Shine ® )

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9865-1Blistex Enhancement Series (Deep Renewal and Silk and Shine)1 in 1 BLISTER PACKKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9865BLISTEX ENHANCEMENT SERIES (DEEP RENEWAL AND SILK AND SHINE) (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE AND OXYBENZONE) KIT [BLISTEX INC.]1Legacy NDC, 1 package rows20150201_44fb78ec-460c-4743-975a-92174b26a0fc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
DimethiconeACTIVE INGREDIENT92RU3N3Y1O1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
DimethiconeACTIVE MOIETY92RU3N3Y1O1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
arachidyl alcoholINACTIVE INGREDIENT1QR1QRA9BU1
arachidyl glucosideINACTIVE INGREDIENT6JVW35JOOJ1
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
castor oilINACTIVE INGREDIENTD5340Y2I9G1
CeresinINACTIVE INGREDIENTQ1LS2UJO3A1
CHONDROITIN SULFATE SODIUM (SHARK)INACTIVE INGREDIENTQ75WVO004L1
dipalmitoyl hydroxyprolineINACTIVE INGREDIENTE6AHA53N1H1
docosanolINACTIVE INGREDIENT9G1OE216XY1
ethylhexyl palmitateINACTIVE INGREDIENT28659933091
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR71
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HE1
MARINE COLLAGEN, SOLUBLEINACTIVE INGREDIENT8JC99XGU4W1
micaINACTIVE INGREDIENTV8A1AW08801
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KY1
mineral oilINACTIVE INGREDIENTT5L8T28FGP1
octyldodecanolINACTIVE INGREDIENT461N1O614Y1
panthenyl ethyl etherINACTIVE INGREDIENTF4WMF8NX3B1
paraffinINACTIVE INGREDIENTI9O0E3H2ZE1
pentaerythrityl tetraethylhexanoateINACTIVE INGREDIENTXJ7052W8971
pentaerythrityl tetraisostearateINACTIVE INGREDIENT9D7IK5483F1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
phenyl trimethiconeINACTIVE INGREDIENTDR0K5NOJ4R1
Polybutene (1400 MW)INACTIVE INGREDIENT1NA5AO9GH71
polytetrafluoroethyleneINACTIVE INGREDIENTE1NC1JVS3O1
PPG-5-Ceteth-20INACTIVE INGREDIENT4AAN25P8P41
saccharinINACTIVE INGREDIENTFST467XS7D1
sandalwoodINACTIVE INGREDIENT3641YW25N21
silica dimethyl silylateINACTIVE INGREDIENTEU2PSP0G0W1
SIMMONDSIA CHINENSIS SEED WAXINACTIVE INGREDIENT47X6Y9FJJ21
sorbic acidINACTIVE INGREDIENTX045WJ989B1
squalaneINACTIVE INGREDIENTGW89575KF91
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZ1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M461
yellow waxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-986510157-9865-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
AvobenzoneG63QQF2NOXACTIB
Octocrylene5A68WGF6WMACTIB
yellow wax2ZA36H0S2VIACT
butylene glycol3XUS85K0RAIACT
dipalmitoyl hydroxyprolineE6AHA53N1HIACT
ethylhexyl palmitate2865993309IACT
lanolin alcohols884C3FA9HEIACT
microcrystalline waxXOF597Q3KYIACT
octyldodecanol461N1O614YIACT
pentaerythrityl tetraisostearate9D7IK5483FIACT
petrolatum4T6H12BN9UIACT
phenoxyethanolHIE492ZZ3TIACT
high density polyethyleneUG00KM4WR7IACT
polytetrafluoroethyleneE1NC1JVS3OIACT
castor oilD5340Y2I9GIACT
saccharinFST467XS7DIACT
silica dimethyl silylateEU2PSP0G0WIACT
hyaluronate sodiumYSE9PPT4THIACT
sorbic acidX045WJ989BIACT
squalaneGW89575KF9IACT
tetrahexyldecyl ascorbate9LBV3F07AZIACT
Polybutene (1400 MW)1NA5AO9GH7IACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
CHONDROITIN SULFATE SODIUM (SHARK)Q75WVO004LIACT
UBIDECARENONEEJ27X76M46IACT
SIMMONDSIA CHINENSIS SEED WAX47X6Y9FJJ2IACT
.alpha.-tocopherol acetate9E8X80D2L0IACT
Dimethicone92RU3N3Y1OACTIB
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
arachidyl alcohol1QR1QRA9BUIACT
arachidyl glucoside6JVW35JOOJIACT
docosanol9G1OE216XYIACT
micaV8A1AW0880IACT
microcrystalline waxXOF597Q3KYIACT
mineral oilT5L8T28FGPIACT
panthenyl ethyl etherF4WMF8NX3BIACT

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 4 · 228 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
castor oilCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YLOTION / TOPICAL714 mgExact identifier — unii candidate
9 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
saccharinSACCHARINFST467XS7DDROPS / ORAL20 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
19 equally ranked IID candidates
CeresinCERESINQ1LS2UJO3ACREAM / VAGINAL280 mgExact identifier — unii candidate
2 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET / ORAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
butylene glycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
squalaneSQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
silica dimethyl silylateSILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE, EXTENDED RELEASE / ORAL4.53 mgExact identifier — unii candidate
18 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / OPHTHALMICNAExact identifier — unii candidate
18 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET / SUBLINGUAL0.2 mgExact identifier — unii candidate
16 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii candidate
4 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Polybutene (1400 MW)POLYBUTENE (1400 MW)1NA5AO9GH7SYSTEM / TRANSDERMAL17.87 mgExact identifier — unii candidate
2 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii candidate
9 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
sorbic acidSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
hyaluronate sodiumHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Polybutene (1400 MW)POLYBUTENE (1400 MW)1NA5AO9GH7FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
2 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0cd06a11-ddec-4cab-91de-086cdbbb1b7344fb78ec-460c-4743-975a-92174b26a0fc2014-12-05WarningsExact identifier
spl id: 0cd06a11-ddec-4cab-91de-086cdbbb1b73
spl set id: 44fb78ec-460c-4743-975a-92174b26a0fc

Reported adverse events (FAERS/openFDA)#

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