Premier Value 318.003/318ah-ai

Premier Value 318.003/318ah-ai
SPL v16
SPL
SPL Set ID d7c047b6-de1f-4e7e-8e4d-6fd80c8f8d2f
Route
ORAL
Published
Effective Date 2025-04-21
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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-08-19 Until 2015-03-28

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

Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) 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
Disclaimer

*This product is not manufactured or directed by Johnson & Johnson Healthcare Poroducts, distributor of Original Listerine Antiseptic Mouthwash.

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.

Questions?

Call 1-888-593-0593

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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO ORIGINAL LISTERINE ANTISEPTIC MOUTHWASH*

Premier Value ®

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

original

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

1 L (33.8 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

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions

Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) 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
Disclaimer

*This product is not manufactured or directed by Johnson & Johnson Healthcare Poroducts, distributor of Original Listerine Antiseptic Mouthwash.

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.

Questions?

Call 1-888-593-0593

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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel (principal display panel)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO ORIGINAL LISTERINE ANTISEPTIC MOUTHWASH*

Premier Value ®

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

original

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

1 L (33.8 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

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