FDA.reportPublic FDA data

Pro Numb Tattoo Numbing Spray 120 mL

Manufacturer
Pro Numb Tattoo Numbing Spray LLC
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:29

Label at a glance#

ProductPro Numb
Active ingredientEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

A sensitivity test is encouraged before using. Spray a small amount on the broken area of the skin. Wait 60 seconds for the anesthetic to start working. Wash Pro Numb off completely before tattooing.

Storage and handling

Store in a cool dark place or refrigerate and keep out of reach of children. Discard the item after the expiration date is due.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 5% Epinephrine HCI .01%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

Temporarily takes away pain, itching, and swelling associated with anorectal disorders or pain-sensitive procedures.

Warnings

WARNINGS SECTION

External Use Only. Keep out of reach of children.

Do not use if you have • seizures or liver disease • if pregnant or breastfeeding • a known allergy or sensitivity occurs, discontinue use, and seek medical attention. If the condition intensifies or symptoms persist for more than seven days or clear up and occur again within a few days, Cease the use of this product and consult a doctor. Do not use in large quantities, Particularly over raw surfaces or blistered areas. Avoid contact with the eyes. If contact should occur, irrigate with large amounts of sterile saline and seek medical attention. Do not swallow, if swallowed, seek medical attention immediately.

When using this product, you may notice temporary whiting or redness of the skin where pro numb is applied.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

A sensitivity test is encouraged before using. Spray a small amount on the broken area of the skin. Wait 60 seconds for the anesthetic to start working. Wash Pro Numb off completely before tattooing.

Other information

STORAGE AND HANDLING SECTION

Store in a cool dark place or refrigerate and keep out of reach of children. Discard the item after the expiration date is due.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified RO water, Paraben-DU, Disodium EDTA, Citric acid, Optiphen.

OTC - QUESTIONS SECTION

Call: (800) 865-4965

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProNumb SprayProNumb Spray120mL Spray NDC: 83389-111-11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EPINEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83389-111-11Pro Numb120 mL in 1 BOTTLE, SPRAYSPRAY1204

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83389-11183389-111-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINE HYDROCHLORIDEWBB047OO38ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
Pro NumbTATTOO NUMBING SPRAYPro Numb Tattoo Numbing Spray LLCf923860d-977a-c55f-e053-6294a90ae9822025-12-05WarningsExact identifier
ndc (package): 83389-111-11
ndc (product): 83389-111
ndc11 (package): 83389011111
spl id: 45375094-9ea8-2376-e063-6394a90a57ea
spl set id: f923860d-977a-c55f-e053-6294a90ae982

Reported adverse events (FAERS/openFDA)#

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