Numfast Tetracaine Green

Manufacturer: Unit Dose, Ltd.
Effective date: 2023-10-19
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:57:58

Label at a glance#

ProductNumfast Tetracaine Green

Active ingredientTETRACAINE

Label structure7 sections

Indications and uses

Temporarily relieves pain from minor scrapes

Dosage and administration

Children under 12 years-ask a doctor Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetracaine 2% w/w

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves pain from minor scrapes

WARNINGS

WARNINGS SECTION

For External Use only

When using this product

OTC - WHEN USING SECTION

Do not get into the eyes
Do not use more than directed
Do not swallow

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain worsens or does not improve within 7 days or cleans up and appears again in a few days
you develop an allergy

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Children under 12 years-ask a doctor

Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.

Questions?

OTC - QUESTIONS SECTION

Call toll free 888/452-4946

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Mineral Oil, Petrolatum, Stearyl Alcohol, Propylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Disodium EDTA, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Blue 1, Yellow 10, BHT

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Numfast

Outer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1733870	NUMFAST 2 % Topical Cream	PSN	5
1733865	tetracaine 2 % Topical Cream	PSN	5
1733870	tetracaine 20 MG/ML Topical Cream [Numfast]	SBD	5
1733865	tetracaine 20 MG/ML Topical Cream	SCD	5
1733870	Numfast 2 % Topical Cream	SY	5
1733870	Numfast 20 MG/ML Topical Cream	SY	5
1733865	tetracaine 2 % Topical Cream	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67194-020-01	Numfast Tetracaine Green	15 g in 1 JAR	CREAM	15		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67194-020	NUMFAST TETRACAINE GREEN (TETRACAINE) CREAM [UNIT DOSE, LTD.]	5	Current NDC, Legacy NDC, 1 package rows	20231027_77d9e6ea-1cd3-4447-ba74-01cd7143e27c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Numfast Tetracaine Green
TETRACAINE
WATER
MINERAL OIL
PETROLATUM
STEARYL ALCOHOL
PROPYLENE GLYCOL
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
POLYOXYL 20 CETOSTEARYL ETHER
EDETATE DISODIUM
TROLAMINE
PROPYLPARABEN
METHYLPARABEN
DIAZOLIDINYL UREA
FD&C BLUE NO. 1
D&C YELLOW NO. 10
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67194-020	67194-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TROLAMINE	9O3K93S3TK	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
TETRACAINE	0619F35CGV	ACTIB

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
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier ndc (package): 67194-020-01 ndc (product): 67194-020 ndc11 (package): 67194002001 spl id: 0814ce6b-2e81-e68b-e063-6294a90a3daf spl set id: 77d9e6ea-1cd3-4447-ba74-01cd7143e27c

Reported adverse events (FAERS/openFDA)#

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