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FDA Approval

Antipyrine and Benzocaine

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

January 17, 2011

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Antipyrine(54 mg in 1 mL)

Benzocaine(14 mg in 1 mL)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (1)

Antipyrine and Benzocaine

NDC Product Code

21695-216

Route of Administration

AURICULAR (OTIC)

Effective Date

December 2, 2009

Ingredients

AntipyrineActive

Code: T3CHA1B51HClass: ACTIBQuantity: 54 mg in 1 mL

BenzocaineActive

Code: U3RSY48JW5Class: ACTIBQuantity: 14 mg in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

OXYQUINOLINE SULFATEInactive

Code: 61VUG75Y3PClass: IACT

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