NDC | 11673-778-04 |
Set ID | 69aeb7c8-9ee6-4b81-91c0-3472f33a5344 |
Category | HUMAN OTC DRUG LABEL |
Packager | Target |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active ingredients Purpose
- Uses
-
Warnings
For external use only
When using this product
- do not use in or near the eyes
- do not apply over large area of the body or in large quantities
- do not apply over raw surfaces or blistered areas
- Directions
- Other information
- Inactive ingredients
- Questions? 1-800-910-6874
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVING CLEANSING
benzalkonium 0.13%, lidocaine hcl 2.5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-778 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 25 mg in 1 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Diazolidinyl Urea (UNII: H5RIZ3MPW4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Methylparaben (UNII: A2I8C7HI9T) NONOXYNOL-9 (UNII: 48Q180SH9T) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-778-04 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/02/2013 Labeler - Target (006961700) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11673-778) , label(11673-778)