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Comfortox Tetracaine

Medically reviewed on September 14, 2016

Dosage form: cream
Ingredients: TETRACAINE HYDROCHLORIDE 20mg in 1000mg
Labeler: Sambria Pharmaceuticals, Inc.
NDC Code: 54723-997

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

COMFORTOX TETRACAINE 
tetracaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-997
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
CHONDROITIN SULFATE SODIUM (BOVINE) 
EMU OIL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
ISOPROPYL PALMITATE 
LAURETH-7 
MELALEUCA ALTERNIFOLIA LEAF 
DIMETHYL SULFONE 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:54723-997-011500 mg in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/14/2016
Labeler - Sambria Pharmaceuticals, Inc. (078676259)
Establishment
NameAddressID/FEIOperations
A.I.G. Technologies, Inc.171837367manufacture(54723-997)
Establishment
NameAddressID/FEIOperations
American Flexpack, Inc.019914600label(54723-997), pack(54723-997)

 
Sambria Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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