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Tetramex Spray

Generic Name: camphor, menthol, tetracaine
Dosage Form: topical spray

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Tetramex

Warnings

For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not apply to open wounds or damaged skin.
Do not use in combination with any external
heat source.
Do not use on irritated or broken skin, or use
in combination with any bandage, wrap, stocking or
similar device or garment.
Consult physician for children under 12 years
of age.
Do not use if allergic to Camphor, Histamine,
Menthol or any other components.
Stop use and consult physician if symptoms
worsen or persist for more than 7 days.
Stop use if itching or excessive skin
irritation occurs.
If pregnant or breast feeding, contact
physician prior to use.

ACTIVE INGREDIENTS:
Camphor 3%
Menthol 1%
Tetracaine HCL 2%
INDICATIONS AND USAGE: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
CLINICAL PHARMACOLOGY: Camphor is used topically to increase local blood flow and as a “counterirritant.” When applied externally, camphor numbs the nerve ending. The nerve endings then no longer transmit the sensation of pain. Menthol instantly brings cool, soothing pain relief to aching muscles. Menthol also has a natural analgesic attribute when applied topically. It has molecules called ligands, which attach themselves to receptors (Kappa Opioid Receptors) in your cell, which produces a numbing effect. Using Menthol topically causes vasodilation, which increases blood flow to the affected area, allowing other medicinal ingredients found in the topical spray to work faster. When applied externally, camphor numbs the nerve ending. The nerve endings then no longer transmit the sensation of pain. Tetracaine is a local anesthetic (numbing medicine). It works by blocking nerve signals in your body. It does this by stopping the sodium entering the nerve ending at the site of the pain. This prevents an electrical signal building up and passing along the nerve fibers to the brain.
CONTRAINDICATIONS: Tetramex is contraindicated in patients with known history of hypersensitivity to local anesthetics, Menthol, camphor, and to other components of Tetramex topical spray. Directions:
Adults and children 12 years and over apply directly to affected area. Do not use more than four times per day. Children under 12 years of age, consult a physician prior to use.
Wash hands with soap before and after use. Avoid contact with eyes and mucous membranes.
WARNING: -For external use only. Use only as directed. -Avoid contact with eyes and mucous membranes. -Do not apply to open wounds or damaged skin. -Do not use in combination with any external heat source. -Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment. -KEEP OUT OF REACH OF CHILDREN. Consult physician for children under 12 years of age. -Do not use if allergic to Menthol, Lidocaine, or any other components. -Stop use and consult physician if symptoms worsen or persist for more than 7 days. -Stop use if itching or excessive skin irritation occurs. -If pregnant or breast feeding, contact physician prior to use.
Other Ingredients: Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia serrata extract, Dimethyl Sulfone, Emu Oil, Ethoxydiglycol, Glucosamine HCL, Glycrrhiza glabra (Licorice) Root Extract, PEG-40, Hydrogenated Castor Oil, Propylene Glycol (and) Diazolidinyl Urea (and) Iodopropynyl Butylcarbamate, SD Alcohol 40B.
How Supplied:
Mentholix is supplied in a 4 ounce (120ml) plastic bottle with a fine mist sprayer for topical application.
Storage:
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Avoid direct sunlight.

Aqua (Deionized Water), Arnica Montana
Flower Extract, Boswellia Serrata
Extract, Dimethyl Sulfone, Emu Oil,
Ethoxydiglycol, Glucosamine HCL,
Glycrrhiza glabra (Licorice) Root Extract,
PEG-40 Hydrogenated Castor Oil,
Propylene Glycol (and) Diazolidinyl Urea
(and) Lodopropynyl Butylcarbamate, SD
Alcohol 40B, Fragrance.

Apply directly to affected area. Do
not use more than four times per day.
Children under 12 years of age:
Consult a Physician.

Camphor............................3.0%
Menthol USP......................1.0%
Tetracaine HCL..................2.0%

KEEP THIS AND ALL MEDICATIONS
OUT OF REACH OF CHILDREN

For temporary relief of minor aches and pains of the
muscles and joints associated with simple backache,
arthritis, strains, bruises and sprains.

Store in 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature]

TETRAMEX 
camphor, menthol, tetracaine spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69094-228
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 3.6 mg  in 1 mL
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 2.4 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL 1.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ARNICA MONTANA FLOWER  
BOSWELLIA SERRATA WHOLE  
DIMETHYL SULFONE  
EMU OIL  
DIETHYLENE GLYCOL MONOETHYL ETHER  
GLUCOSAMINE HYDROCHLORIDE  
LICORICE  
CASTOR OIL  
PROPYLENE GLYCOL  
DIAZOLIDINYL UREA  
BUTYL CARBAMATE  
ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:69094-228-04 120 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/24/2014
Labeler - 1st Class Pharmaceuticals (079448685)
Revised: 03/2015
 
1st Class Pharmaceuticals



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