NDC | 57483-108-05 |
Set ID | 158c7036-1a48-48c4-960c-cf99a7aa9cb1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Innovus Pharmaceuticals, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop and ask a doctor if
- Keep out of reach of children.
-
Directions
- When practical, clean area with mild soap and warm water and rinse thoroughly, Gently dry by patting or blotting wiht toilet tissue or soft cloth before applying.
- Adults and children 12 years and older: Apply externally to the affected are up to six times a day
- Children under 12 years of age: Consult a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
XYRALID
lidocaine 5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-108 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-108-05 30 in 1 CARTON 07/14/2017 1 .5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/06/2017 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Registrant - Innovus Pharmaceuticals, Inc. (962507187)