FDA.reportPublic FDA data

Dyve Comfort L

Manufacturer
AmperSand Biopharmaceuticals
Effective date
2018-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:05

Label at a glance#

ProductDyve Comfort L
Active ingredientMENTHOL, LIDOCAINE
Label structure9 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

Storage and handling

Store at 20-25ºC (68-77ºF)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor

When using this product:

OTC - WHEN USING SECTION

Use only as directed

Read and follow all direction and warnings on this carton

Do not allow contact with eyes

Do not bandage or apply local heat to the area of use

Stop using and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water

Questions?

OTC - QUESTIONS SECTION

1-833-DYVE-BIO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dyve Comfort L boxDyve Comfort L box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN1
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD1
1804176lidocaine 4 % / menthol 1 % Topical GelSY1

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
70458-103-202020-01-31C16284748780-19d75b9d0-11f2-f424-e053-dadaa90a57ce67e42947-3e05-c72c-e053-2991aa0adb99

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70458-103-20Dyve Comfort L200 g in 1 JARGEL2001
70458-103-20Dyve Comfort L1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70458-103DYVE COMFORT L (MENTHOL, LIDOCAINE) GEL [AMPERSAND BIOPHARMACEUTICALS]1Legacy NDC, 2 package rows20180401_67e42947-3e05-c72c-e053-2991aa0adb99.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70458-10370458-103-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LIDOCAINE98PI200987ACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
POLOXAMER 407TUF2IVW3M2IACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
POLYGLYCERYL-4 STEARATEVLC3W3U1PEIACT
PALM KERNEL OILB0S90M0233IACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
67e42947-3e06-c72c-e053-2991aa0adb9967e42947-3e05-c72c-e053-2991aa0adb992018-03-20WarningsExact identifier
spl id: 67e42947-3e06-c72c-e053-2991aa0adb99
spl set id: 67e42947-3e05-c72c-e053-2991aa0adb99

Reported adverse events (FAERS/openFDA)#

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