71927-006

71927-006
SPL v2
SPL
SPL Set ID 873c43df-1d46-359b-e053-2a91aa0a4319
Route
ORAL
Published
Effective Date 2019-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-22
Description

Active ingredients EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Medication Information

Warnings and Precautions

Warnings

Stop use and see your dentist immediately if

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth

These may be signs or symptoms of periodontitis, a serious form of gum disease.

Indications and Usage

Uses

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Dosage and Administration

Directions

adult and children 12 years of age and older vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
children 6 to 20 years of age supervise use
children uner 6 years of age do not use

Description

Active ingredients EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Section 50565-1

Keep out of reach of children under 6 years of age . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 55105-1

Purpose

Antigingivitis, Antiplaque

Section 55106-9

Active ingredients

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Section 60561-8

Other information

  • not intended to replace brushing or flossing
  • store at room temperature (59-77F)
  • cold weather may cloud this product, but will not affect its antiseptic properties.

Structured Label Content

Indications and Usage (34067-9)

Uses

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums
Dosage and Administration (34068-7)

Directions

adult and children 12 years of age and older vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
children 6 to 20 years of age supervise use
children uner 6 years of age do not use

Warnings and Precautions (34071-1)

Warnings

Stop use and see your dentist immediately if

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth

These may be signs or symptoms of periodontitis, a serious form of gum disease.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antigingivitis, Antiplaque

Section 55106-9 (55106-9)

Active ingredients

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

Section 60561-8 (60561-8)

Other information

  • not intended to replace brushing or flossing
  • store at room temperature (59-77F)
  • cold weather may cloud this product, but will not affect its antiseptic properties.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.151563 · Updated: 2026-03-14T23:08:14.770901