NDC | 11523-0404-1, 11523-0404-2 |
Set ID | df8a384d-2263-43e8-94bd-1c7dbea9bc03 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bayer HealthCare LLC. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
Do not use in large quantities, particularly over raw surfaces or blistered areas
When using this product
- keep out of eyes
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 170 g Can Label
-
INGREDIENTS AND APPEARANCE
SOLARCAINE
lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0404 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color white (Viscous hazy colorless to off-white liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0404-1 127 g in 1 CAN; Type 0: Not a Combination Product 03/01/2016 2 NDC:11523-0404-2 170 g in 1 CAN; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/06/2012 Labeler - Bayer HealthCare LLC. (112117283)