Antiseptic
Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDC
Approved
Approval ID
f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jan 10, 2025
Manufacturers
FDA
Family Dollar (FAMILY WELLNESS)
DUNS: 024472631
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55319-290
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2025
FDA Product Classification
INGREDIENTS (13)
MENTHOLActive
Quantity: 0.42 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 0.6 mg in 1 mL
Code: LAV5U5022Y
Classification: ACTIB
THYMOLActive
Quantity: 0.64 mg in 1 mL
Code: 3J50XA376E
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
EUCALYPTOLActive
Quantity: 0.92 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT