MedPath

Antispetic

Exchange Select 664.003/664AU Blue Mint Antiseptic Mouthrinse

Approved
Approval ID

d0ede39c-4b05-47c7-9c0b-9e893dcdb723

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

Your Military Exchanges

DUNS: 001695568

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 Code55301-664
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eucalyptol, menthol, methyl salicylate, thymol
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
EUCALYPTOLActive
Quantity: 0.92 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB
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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/10/2025

principal display panel

Compare to Cool Mint ®Listerine ® Antiseptic Mouthwash*

Exchange Select™

Blue Mint

ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause bad breath, plaque and gingivitis gum disease

quality vlaue

3.2 FL OZ (94 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/10/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/10/2025

Adverse Reactions

"SATISFACTION GUARANTEED OR YOUR MONEY BACK"

Manufactured For Your Military Exchanges

By: Consumer Product Partners, LLC

St. Louis, MO 63114 1-888-593-0593

DSP-TN-21091

DSP-MO-20087

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/10/2025

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/10/2025

Purpose

Antigingivitis, antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 6/10/2025

Warnings

For this product

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/10/2025

Do not use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/10/2025

Claim

Meets current TSA guidelines for carry-on luggage.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/10/2025

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/10/2025

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/10/2025

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/10/2025

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

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Antispetic - FDA Drug Approval Details