Siterol

Manufacturer
Binger Consulting Corporation | Active Intelligence, LLC
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:39:38

Label at a glance#

ProductSiterol
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

• temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations

Dosage and administration

How to apply • clean and dry affected area • remove patch from backing and apply to affected area • use only one patch at a time, and maximum of four patches/day • leave patch on affected area for upto 8-hours • do not use patches for longer than five consecutive days

Storage and handling

Other information store below 25°C (77° F), avoid direct sunlight

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 3.99%

Menthol 1.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

External Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Consult physician for children under 12.

Uses

INDICATIONS & USAGE SECTION

• temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Do not use

• if pregnant or breastfeeding, consult physician prior to use

• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• use only as directed • do not bandage tightly • avoid contact with eyes

• do not apply to open wounds or damaged skin

Stop use and ask a doctor if

• symptoms persist for more than seven days, discontinue use and consult physician

• swallowed, consult physician

Directions

DOSAGE & ADMINISTRATION SECTION

How to apply • clean and dry affected area • remove patch from backing and apply to affected area • use only one patch at a time, and maximum of four patches/day • leave patch on affected area for upto 8-hours • do not use patches for longer than five consecutive days

INACTIVE INGREDIENT SECTION

Other ingredients aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), arnica montana extract, boswellia serrata extract, camellia sinensis leaf (green tea) extract, carbomer, ethylhexylglycerin, glycerin, isopropyl myristate, PEG-8, phenoxyethanol, polysorbate-80, sodium lauryl sulfate, triethanolamine, FD C blue 1, FD C yellow 5

OTC - QUESTIONS SECTION

Questions or comments? ​ ​call weekdays from 9 AM to 5 PM PST 888-501-5651

STORAGE AND HANDLING SECTION

Other information store below 25°C (77° F), avoid direct sunlight

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SiterolSiterol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN5
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD5
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69440-007-152021-10-21C16284748780-1c7ccaba7-1605-fd44-e053-dadaa90aa01bSiterol
69440-007-152021-07-23C16284748780-1c7ccaba7-1605-fd44-e053-dadaa90aa01bSiterol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69440-007-15Siterol15 in 1 BOXPATCH155
69440-007-15Siterol100 g in 1 PATCHPATCH1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69440-007SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]5Legacy NDC, 2 package rows20241129_1ef21407-5fd2-4349-8d4f-af3b13dab476.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69440-007-15EA - Each69440-007e623ab55-7f34-4f8c-b64e-a423f79d8dbf12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A2
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3A2
LIDOCAINEACTIVE MOIETY98PI2009872
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZW2
BOSWELLIA SACRA WHOLEINACTIVE INGREDIENT8O600AZL0W2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV362
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
PEG-8 GLYCERYL ISOSTEARATEINACTIVE INGREDIENT74QQ5X3KL12
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
TRIETHANOLAMINE BENZOATEINACTIVE INGREDIENTM3EN4GC19W2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69440-00769440-007-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 · 284 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / ORAL1 mg/1mlExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
78 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSFILM / TRANSDERMAL58.08 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / DENTAL1.47 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / VAGINAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / SUBLINGUAL1.1 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, FILM COATED / ORAL1.68 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS53 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36FILM, EXTENDED RELEASE / TRANSDERMAL38.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSUSPENSION / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 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
0dcb705d-cf61-45a8-937d-96ce6b873cfa1ef21407-5fd2-4349-8d4f-af3b13dab4762024-11-27WarningsExact identifier
spl id: 0dcb705d-cf61-45a8-937d-96ce6b873cfa
spl set id: 1ef21407-5fd2-4349-8d4f-af3b13dab476

Reported adverse events (FAERS/openFDA)#

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