MedPath
FDA Approval

Ban-Aid

Pro Chem, Inc. (DUNS: 061396065)

April 22, 2025

HUMAN OTC DRUG LABEL

Chloroxylenol(3 mg in 1 mL)

Registrants (1)

ABC Compounding Co., Inc.

003284353

Manufacturing Establishments (1)

ABC Compounding Co., Inc.

Pro Chem, Inc.

ABC Compounding Co., Inc.

003284353

Products (1)

Ban-Aid

63830-544

M003

OTC Monograph Drug (C200263)

TOPICAL

April 22, 2025

WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0Class: IACT
DECYL GLUCOSIDEInactive
Code: Z17H97EA6YClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
Code: 0F32U78V2QClass: ACTIBQuantity: 3 mg in 1 mL
DMDM HYDANTOINInactive
Code: BYR0546TOWClass: IACT
COCO MONOISOPROPANOLAMIDEInactive
Code: 21X4Y0VTB1Class: IACT
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