Label: MEDICAINE STING AND BITE- benzocaine swab
- NDC Code(s): 46414-2040-3
- Packager: James Alexander Corporation
- 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 January 31, 2019
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- Active Ingredients (each swab)
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INGREDIENTS AND APPEARANCE
MEDICAINE STING AND BITE
benzocaine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46414-2040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) BENZOCAINE 0.12 g in 0.6 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.006 g in 0.6 mL Inactive Ingredients Ingredient Name Strength D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46414-2040-3 6 mL in 1 CARTON; Type 0: Not a Combination Product 11/15/1986 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/1986 Labeler - James Alexander Corporation (040756421) Registrant - James Alexander Corporation (040756421) Establishment Name Address ID/FEI Business Operations James Alexander Corporation 040756421 manufacture(46414-2040)