FDA.reportPublic FDA data

DermaNumb Tattoo Anesthetic Gel

Manufacturer
A.T.S. Laboratories, LLC
Effective date
2018-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:04:51

Label at a glance#

ProductDermaNumb Tattoo Anesthetic Gel
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

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
70188-00270188-002-02

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
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

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
906ff0b1-8f99-4cb5-bcac-b412629cb25976ae255d-03e3-4c13-8d12-e430bbaac9572018-01-17WarningsExact identifier
spl id: 906ff0b1-8f99-4cb5-bcac-b412629cb259
spl set id: 76ae255d-03e3-4c13-8d12-e430bbaac957

Reported adverse events (FAERS/openFDA)#

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