Walgreens 072.003/072al Rev 2-072an

Walgreens 072.003/072al Rev 2-072an
SPL v17
SPL
SPL Set ID cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0
Route
ORAL
Published
Effective Date 2025-02-18
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 Solution Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-03-30 Until 2013-08-14

Description

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

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

‡This product is not manufactured or distributed by Kenvue, Inc., distributor of Freshburst® Listerine® Antiseptic Mouthwash. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com 1-800-925-4733 W3ORG0924-F DSP-TN-21081 DSP-MO-80087 ITEM 771870 W10100-1024-F


Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

‡This product is not manufactured or distributed by Kenvue, Inc., distributor of Freshburst® Listerine® Antiseptic Mouthwash.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com 1-800-925-4733

W3ORG0924-F

DSP-TN-21081 DSP-MO-80087

ITEM 771870 W10100-1024-F

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
  • do not swallow
  • not intended to replace brushing or flossing

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



Children under 12 years of age - Consult a dentist or doctor

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.

Other Information

Store at room temperature (59⁰ - 77⁰F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Walgreens

NEW

Compare to the active ingredients in Freshburst® Listerine® Antiseptic Mouthwash‡

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

Antiseptic

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

ADA Accepted

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

8.5 FL OZ (250 mL)

Mint flavor

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.

Stop Use and Ask A Dentist If 

Gingivitis, bleeding or redness persists for more than 2 weeks


Structured Label Content

Use

 helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions
  • do not swallow
  • not intended to replace brushing or flossing

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



Children under 12 years of age - Consult a dentist or doctor

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.

Adverse Reactions (ADVERSE REACTIONS)

‡This product is not manufactured or distributed by Kenvue, Inc., distributor of Freshburst® Listerine® Antiseptic Mouthwash.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com 1-800-925-4733

W3ORG0924-F

DSP-TN-21081 DSP-MO-80087

ITEM 771870 W10100-1024-F

Other Information (Other information)

Store at room temperature (59⁰ - 77⁰F)

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, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

Principal Display Panel (principal display panel)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Walgreens

NEW

Compare to the active ingredients in Freshburst® Listerine® Antiseptic Mouthwash‡

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

Antiseptic

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

ADA Accepted

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

8.5 FL OZ (250 mL)

Mint flavor

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.

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

Gingivitis, bleeding or redness persists for more than 2 weeks


Advanced Ingredient Data


Raw Label Data

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