COMFORTOX TETRACAINE- tetracaine hcl cream

Comfortox Tetracaine by

Drug Labeling and Warnings

Comfortox Tetracaine by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, Inc., A.I.G. Technologies, Inc., American Flexpack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredients

Tetracaine HCL     2.0% w/w

​Purpose

External Analgesic

​Uses

For temporary relief of pain and itching due to minor skin irritation

WARNINGS

​For external use only

Avoid contact with eyes

DO NOT USE

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

STOP USE

​Stop use and ask a doctor if​

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

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children​

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

​Directions

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

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

​Other Information

Protect this product from excessive heat and direct sun.

​Questions or Comments?

FDA Registered: NDC No. 54723-997-01

800-693-9067

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMFORTOX TETRACAINE 
tetracaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-997
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	20 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-997-01	1500 mg in 1 PACKET; Type 0: Not a Combination Product	09/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/14/2016

Labeler - Sambria Pharmaceuticals, Inc. (078676259)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(54723-997)

Establishment
Name	Address	ID/FEI	Business Operations
JP Packaging LLC		151369456	repack(54723-997)