FDA.reportPublic FDA data

DermaNumb Gel

Manufacturer
A.T.S. Laboratories, LLC | Southeast Holdings Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:43:15

Label at a glance#

ProductDermaNumb Analgesic
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

For temporary relief of pain and itching associated with minor cuts or minor skin irritations.

Dosage and administration

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.0% w/w

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor cuts or minor skin irritations.

Warnings

WARNINGS SECTION

​For external use only

Avoid contact with eyes

OTC - DO NOT USE SECTION

​Do not use ​in large quantities, particularly over raw surfaces or blistered areas

OTC - STOP USE SECTION

​Stop use and ask doctor if​

​• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days.  Discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children​

• If product is swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Achillea Millegolium (Yarrow) Extract, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

954-492-9898

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1747492Derma Numb 4 % Topical GelPSN9
1010077lidocaine HCl 4 % Topical GelPSN9
1747492lidocaine hydrochloride 0.04 MG/MG Topical Gel [Derma Numb]SBD9
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD9
1747492Derma Numb 0.04 MG/MG Topical GelSY9
1747492Derma Numb 4 % Topical GelSY9
1010077lidocaine hydrochloride 4 % Topical GelSY9

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70188-006-01DermaNumb Analgesic57 g in 1 PACKAGEGEL579

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70188-00670188-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
MENTHOLL7T10EIP3AIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
YUCCA SCHIDIGERA08A0YG3VICIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-08full-release2026-06-01 00:41:18

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
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
ndc (package): 70188-006-01
ndc (product): 70188-006
ndc11 (package): 70188000601
spl id: 4357221e-618b-66aa-e063-6394a90a6ccf
spl set id: 0ea46890-45c3-4732-bc47-227f7c67daf1

Reported adverse events (FAERS/openFDA)#

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