NDC | 37945-212-34, 37945-212-35 |
Set ID | 3a477714-6ff3-62aa-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Bio-Medical & Pharmaceutical Manufacturing Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Drug Facts
- Active Ingredient
- Purpose
- Indications
-
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
-
INGREDIENTS AND APPEARANCE
BURN CREAM
tetracaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-212 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 YELLOW WAX (UNII: 2ZA36H0S2V) SODIUM BORATE ANHYDROUS (UNII: 8191EN8ZMD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-212-35 12 in 1 BOX 08/19/2016 1 NDC:37945-212-34 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 08/19/2016 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-212)