Twice. Oral Wellness Gum Shield Mouthwash

Twice. Oral Wellness Gum Shield Mouthwash
SPL v2
SPL
SPL Set ID 3d48e2f6-99b6-e8bc-e063-6294a90a1afc
Route
ORAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.5 mg)
Inactive Ingredients
Citric Acid Disodium Phosphate Lemon Oil Water Poloxamer 407 Spearmint Oil Glycerin Stevia Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01
Description

Cetylpyridinium Chloride 0.05%

Purpose

Antigingivitis/Antiplaque mouthrinse

Medication Information

Purpose

Antigingivitis/Antiplaque mouthrinse

Description

Cetylpyridinium Chloride 0.05%

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that lead to gingivitis and bleeding gums
Section 51945-4

Warnings

Warnings

Directions

Adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. Do not swallow the rinse.

Children 6 years to under 12 yaers: Supervise use.

Children under 6 years: Do not use.

Active Ingredient

Cetylpyridinium Chloride 0.05%

Other Information

This rinse is not intended to replace brushing or flossing, Do not use if printed safety seal on the bottle's neck is broken or missing, Recommended storage temperature 59°F-77°F (15°C-25°C)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water

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 right away (1-800-222-1222).

Stop Use and Ask A Dentist 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 spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease

Structured Label Content

Uses
  • Helps prevent gingivitis, an early form of gum disease, and bleeding gums
  • Helps control plaque that lead to gingivitis and bleeding gums
Section 51945-4 (51945-4)

Purpose

Antigingivitis/Antiplaque mouthrinse

Warnings

Warnings

Directions

Adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. Do not swallow the rinse.

Children 6 years to under 12 yaers: Supervise use.

Children under 6 years: Do not use.

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.05%

Other Information (Other information)

This rinse is not intended to replace brushing or flossing, Do not use if printed safety seal on the bottle's neck is broken or missing, Recommended storage temperature 59°F-77°F (15°C-25°C)

Inactive Ingredients (Inactive ingredients)

Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water

Keep Out of Reach of Children (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 right away (1-800-222-1222).

Stop Use and Ask A Dentist If (Stop use and ask a dentist 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 spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:39.676693 · Updated: 2026-03-14T23:12:58.166895