53943-514-50 Antiseptic Mouthwash

53943-514-50 Antiseptic Mouthwash
SPL v3
SPL
SPL Set ID d00e472f-78f2-3d36-e053-2995a90ac267
Route
ORAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.6 mg) Menthol (0.42 mg) Thymol (0.64 mg) Eucalyptol (0.92 mg)
Inactive Ingredients
Caramel Alcohol Poloxamer 407 Water Benzoic Acid Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01
Description

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

Purpose

Antiplaque/Antigingivitis

Medication Information

Purpose

Antiplaque/Antigingivitis

Description

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

Uses

to help reduce and prevent plaque and gingivitis.

Warnings

Do not use for children under 12 years of age.

Directions
  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • Do not swallow.
Other Information
  • store at room temperature.
  • cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Inactive Ingreduebts

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Keep Out of Reach of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Package Principal Display Panel

Structured Label Content

Uses

to help reduce and prevent plaque and gingivitis.

Purpose

Antiplaque/Antigingivitis

Warnings

Do not use for children under 12 years of age.

Directions
  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • Do not swallow.
Other Information
  • store at room temperature.
  • cold weather may cloud this product. Its antiseptic properties are not affected.
Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Inactive Ingreduebts

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

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 immediately (1-800-222-1222).

Package Principal Display Panel

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:54.993984 · Updated: 2026-03-14T23:04:16.644897