COMFORTOX TETRACAINE- tetracaine hcl cream 
Sambria Pharmaceuticals, Inc.

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Comfortox T

​Active Ingredients

Tetracaine HCL     2.0% w/w

​Purpose

External Analgesic

​Uses

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

​For external use only

Avoid contact with eyes

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

​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

• 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

packet

COMFORTOX TETRACAINE 
tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-997
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-997-011500 mg in 1 PACKET; Type 0: Not a Combination Product09/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/14/2016
Labeler - Sambria Pharmaceuticals, Inc. (078676259)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.086365223manufacture(54723-997)

Revised: 11/2023
Document Id: 094099ac-1a05-7d6b-e063-6394a90a936b
Set id: 90f644b4-faa2-4f54-865a-44ccdab99ad3
Version: 6
Effective Time: 20231103
 
Sambria Pharmaceuticals, Inc.