NDC | 0924-5200-01, 0924-5200-02, 0924-5200-03 |
Set ID | cee0edef-133f-404e-ba69-e14b602979c2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Acme United Corporation |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART333E |
- SPL UNCLASSIFIED SECTION
- Active Ingredient:
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- Uses
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- Principal Display Panel - Carton Label
- Principal Display Panel - Carton Label
- Principal Display Panel - Packet Label
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INGREDIENTS AND APPEARANCE
STING RELIEF
alcohol, lidocaine hydrochloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 0.50 mL in 1 mL lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride (UNII: F5UM2KM3W7) menthol (UNII: L7T10EIP3A) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5200-02 10 in 1 BOX 03/06/2012 1 NDC:0924-5200-01 0.9 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-5200-03 50 in 1 BOX 03/06/2012 2 NDC:0924-5200-01 0.9 mL 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 not final part333E 03/06/2012 Labeler - Acme United Corporation (001180207) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(0924-5200)