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FDA Product

DEBACTEROL Canker Sore Pain Relief

Product approved by U.S. Food and Drug Administration (US)

Basic Information

DEBACTEROL Canker Sore Pain Relief

62942-101

Regulatory Information

62942-101

November 30, 2021

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

EPIEN Medical Inc

128678765

Active Ingredients

WATER

Quantity: 0.2 g in 1 mL

Code: 059QF0KO0R

Class Code: IACT

PHENOLSULFONIC ACID

Quantity: 0.5 g in 1 mL

Code: L74LRO149A

Class Code: ACTIB

SULFURIC ACID

Quantity: 0.3 g in 1 mL

Code: O40UQP6WCF

Class Code: ACTIB

Active Moieties

SULFURIC ACID

Code: O40UQP6WCF

PHENOLSULFONIC ACID

Code: L74LRO149A

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