Dyve Comfort B

Manufacturer: AmperSand Biopharmaceuticals
Effective date: 2018-03-21
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 B

Active ingredientMENTHOL, BENZOCAINE

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

Benzocaine 20%

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

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 B - 200 gram jar box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2003131	benzocaine 20 % / menthol 1 % Topical Gel	PSN	1
2003131	benzocaine 0.2 MG/MG / menthol 0.01 MG/MG Topical Gel	SCD	1
2003131	benzocaine 20 % / menthol 1 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70458-104-20	2020-01-31	C162847	48780-1	9d75b9cf-e66c-f424-e053-dadaa90a57ce	67ef2aad-b290-c0c8-e053-2991aa0a6093

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70458-104-20	Dyve Comfort B	1 in 1 BOX	GEL	1		1
70458-104-20	Dyve Comfort B	200 g in 1 JAR	GEL	200		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70458-104	DYVE COMFORT B (BENZOCAINE, LIDOCAINE) GEL [AMPERSAND BIOPHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20180401_67ef2aad-b290-c0c8-e053-2991aa0a6093.zip

Products#

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

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

Dyve Comfort B
Benzocaine, lidocaine
MENTHOL
ISOPROPYL PALMITATE
BENZOCAINE
LECITHIN, SOYBEAN
POLOXAMER 407
BENZYL ALCOHOL
WATER
POLYGLYCERYL-4 STEARATE
PALM KERNEL OIL
POLYGLYCERYL-4 OLEATE
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70458-104	70458-104-20

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
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
BENZOCAINE	U3RSY48JW5	ACTIB
LECITHIN, SOYBEAN	1DI56QDM62	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
WATER	059QF0KO0R	IACT
POLYGLYCERYL-4 STEARATE	VLC3W3U1PE	IACT
PALM KERNEL OIL	B0S90M0233	IACT
POLYGLYCERYL-4 OLEATE	15B05TY4GX	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
67ef2aad-b291-c0c8-e053-2991aa0a6093			67ef2aad-b290-c0c8-e053-2991aa0a6093	2018-03-21	Warnings	Exact identifier spl id: 67ef2aad-b291-c0c8-e053-2991aa0a6093 spl set id: 67ef2aad-b290-c0c8-e053-2991aa0a6093

Reported adverse events (FAERS/openFDA)#

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