FDA.reportPublic FDA data

SYREN Intimate Relief Gel

Manufacturer
Icon Health Science
Effective date
2024-09-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:04

Label at a glance#

ProductSYREN Intimate Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Adults and children two-years of age or older:  Apply to affected area not more than three to four times daily. Children under twelve-years of age:  consult a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4.00%

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching, cuts, scrapes, and minor skin irritations.

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days discontinue use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

OTC - DO NOT USE SECTION

  • Do not apply to wounds or damaged skin.
  • Wash hands after use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older:  Apply to affected area not more than three to four times daily.
  • Children under twelve-years of age:  consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Benzoic Acid, Cannabis Sativus (Hemp) Seed Oil, Carbomer, Carrageenan, Ethylhexylglycerin, I-Arginine, PEG-8, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tocopherol Acetate (Vitamin E), Triethanolamine.

Package Labeling: 1oz/30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NewCartonNewCarton

InnerLabelInnerLabel

Package Labeling: 1oz/30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package01Outer Package01Inner Package01Inner Package01

Package Labeling: 2.5oz/74ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package002Outer Package002Inner Package002Inner Package002

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69233-843-00SYREN Intimate Relief30 mL in 1 BOTTLE, PUMPGEL304
69233-843-00SYREN Intimate Relief1 in 1 BOXGEL14
69233-843-01SYREN Intimate Relief30 mL in 1 TUBEGEL304
69233-843-01SYREN Intimate Relief1 in 1 BOXGEL14
69233-843-02SYREN Intimate Relief74 mL in 1 JARGEL744
69233-843-02SYREN Intimate Relief1 in 1 BOXGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69233-843SYREN INTIMATE RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [ICON HEALTH SCIENCE]4Current NDC, Legacy NDC, 6 package rows20240927_57d5a080-3583-4510-e053-2a91aa0ad589.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69233-84369233-843-01, 69233-843-00, 69233-843-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BENZOIC ACID8SKN0B0MIMIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CARRAGEENAN5C69YCD2YJIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

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
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
ndc (package): 69233-843-00
ndc (package): 69233-843-01
ndc (package): 69233-843-02
ndc (product): 69233-843
ndc11 (package): 69233084302
ndc11 (package): 69233084300
ndc11 (package): 69233084301
spl id: 22ed7dd1-a570-eb7a-e063-6394a90ae251
spl set id: 57d5a080-3583-4510-e053-2a91aa0ad589

Reported adverse events (FAERS/openFDA)#

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