TWICE. ORAL WELLNESS GUM SHIELD- cetylpyridinium chloride rinse

twice. Oral Wellness Gum Shield by

Drug Labeling and Warnings

twice. Oral Wellness Gum Shield by is a Otc medication manufactured, distributed, or labeled by Twice Twice LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Antigingivitis/Antiplaque mouthrinse

Uses

• Helps prevent gingivitis, an early form of gum disease, and bleeding gums
• Helps control plaque that lead to gingivitis and bleeding gums

Warnings

Warnings

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

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).

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)

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.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TWICE. ORAL WELLNESS GUM SHIELD 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72164-009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SPEARMINT OIL (UNII: C3M81465G5)
GLYCERIN (UNII: PDC6A3C0OX)
STEVIA LEAF (UNII: 6TC6NN0876)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72164-009-20	591 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/01/2025

Labeler - Twice Twice LLC (119381782)