Premier Value 664.003/664at Rev 2-au

Premier Value 664.003/664at Rev 2-au
SPL v15
SPL
SPL Set ID 9e83e4eb-4a74-4646-812e-1d208043e2c4
Route
ORAL
Published
Effective Date 2025-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-05-15 Until 2026-02-01

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Adverse Reactions

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue, Wayne, PA 19087 DSP-TN-15000 DSP-MO-34 SDS-TN-15012


Medication Information

Purpose

Antigingivitis, antiplaque

Adverse Reactions

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne, PA 19087

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth 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
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.

Disclaimers

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic mouthwash.

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO COOL MINT LISTERINE ANTSEPTIC MOUTHWASH*

Premier Value ®

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

blue mint

kils germs that cause bad breath, plaque & the gum disease gingivitis

PV

500 mL (16.9 FL OZ)

Stop Use and Ask A Dentist If

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

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.


Structured Label Content

Use (use)

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, antiplaque

Warnings

For this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth 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
Do Not Use (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.

Disclaimers

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic mouthwash.

Adverse Reactions

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne, PA 19087

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Other Information (Other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO COOL MINT LISTERINE ANTSEPTIC MOUTHWASH*

Premier Value ®

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

blue mint

kils germs that cause bad breath, plaque & the gum disease gingivitis

PV

500 mL (16.9 FL OZ)

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

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

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)