Label: BURN SOLUTION CREAM- tetracaine cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70704-212-20 - Packager: Burn Solution Foundations
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70704-212-20 1 in 1 BOX 02/02/2021 1 5.6 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 02/02/2021 Labeler - Burn Solution Foundations (085996883) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(70704-212)