BURN SOLUTION CREAM- tetracaine cream cream 
Burn Solution Foundations

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.

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Drug Facts

Topical Burn Cream plus Pain Relief

Active ingredient

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

Purpose

For temporary relief of minor aches and pains of muscles and joints commonly associated 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, FL
888.368.0555
http://relief-roller.com

starell starell

BURN SOLUTION CREAM 
tetracaine cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70704-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BORATE ANHYDROUS (UNII: 8191EN8ZMD)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70704-212-201 in 1 BOX02/02/2021
15.6 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/02/2021
Labeler - Burn Solution Foundations (085996883)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(70704-212)

Revised: 4/2021
Document Id: c0e3c44c-b7bf-da89-e053-2a95a90a3482
Set id: b95bad36-668d-0954-e053-2995a90ab0f3
Version: 3
Effective Time: 20210426
 
Burn Solution Foundations