NUMFAST TETRACAINE GREEN- tetracaine cream

Numfast Tetracaine Green by

Drug Labeling and Warnings

Numfast Tetracaine Green by is a Otc medication manufactured, distributed, or labeled by Unit Dose, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Tetracaine 2% w/w

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain from minor scrapes

WARNINGS

For External Use only

When using this product

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

Stop use and ask a doctor if

• 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

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

Directions:

​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?

​Call toll free 888/452-4946

Inactive Ingredients:

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:

INGREDIENTS AND APPEARANCE

NUMFAST TETRACAINE GREEN 
tetracaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67194-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	20 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67194-020-01	15 g in 1 JAR; Type 0: Not a Combination Product	01/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/20/2016

Labeler - Unit Dose, Ltd. (119080393)