- DRUG FACTS
- Active Ingredient Purpose
- Purpose
- Indications
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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
- Other Information
- Inactive Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN SOLUTION CREAM
tetracaine cream creamProduct 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)