BURN SOLUTION CREAM- tetracaine cream cream

Burn Solution Cream by

Drug Labeling and Warnings

Burn Solution Cream by is a Otc medication manufactured, distributed, or labeled by Burn Solution Foundations, Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Topical Burn Cream Plus Pain Relief

Active Ingredient Purpose

Tetracaine (1.0%).......................Pain & Itch Relief

Purpose

For temporary relief of minor aches and pains of muscles and joints commonly assoicated with backache, arthritis, strains, bruises, sprains, and burns.

Indications

For cooling, deep-penetrating pain relief, apply a thin layer sparingly to affected areas.
Apply up to 3 times daily.

Warnings

Not for use on children under 2 years old except as directed by a doctor.
Avoid contact with the eyes.
For external use only.
If irritation develops and persists, discontinue use and consult a doctor.
If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Directions

Apply this product topically to affected areas.
Use up to 3 times daily.
Use only as directed.

Other Information

External Anesthetic

Inactive Ingredients

Water, Stearic Acid, Lauramide DEA, Beeswax, Propylene Glycol, Sodium Tetraborate, Sodium Lauryl Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Eucalyptus Oil.

Questions or Comments

Burn Solution Foundation

Land O Lakes, Florida

8am - 5pm M-F

Phone: (813) 803-3876

Internet: www.burnsolutionfoundation.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN SOLUTION CREAM 
tetracaine cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70704-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE ANHYDROUS (UNII: 8191EN8ZMD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70704-212-35	12 in 1 BOX	08/23/2016
1	NDC: 70704-212-34	10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/23/2016

Labeler - Burn Solution Foundations (085996883)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(70704-212)