Label: SOLARCAINE- lidocaine spray
- NDC Code(s): 11523-0404-1, 11523-0404-2
- Packager: Bayer HealthCare LLC.
- 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 May 16, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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
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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)