LISTERINE GUM THERAPY ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

Listerine Gum Therapy Antiseptic by

Drug Labeling and Warnings

Listerine Gum Therapy Antiseptic by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Eucalyptol (0.092%)	Antiplaque/antigingivitis
Menthol (0.042%)	Antiplaque/antigingivitis
Methyl Salicylate (0.060%)	Antiplaque/antigingivitis
Thymol (0.064%)	Antiplaque/antigingivitis

Use

helps prevent and reduce:

• plaque
• gingivitis

Warnings

Do not use in children under 12 years of age

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.

Directions

• rinse full strength for 30 seconds with 20mL (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.

Inactive ingredients

Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Flavor, Sodium Saccharin, Blue 1

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

ANTISEPTIC
LISTERINE
GUM THERAPY
4X
HEALTHIER*

HELPS REVERSE SIGNS OF
EARLY GUM DISEASE: REDNESS,
BLEEDING AND INFLAMMATION

GLACIER MINT
1.0 L (1 Qt 1.8 Fl Oz)

INGREDIENTS AND APPEARANCE

LISTERINE GUM THERAPY ANTISEPTIC 
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0604
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK)	Eucalyptol	0.92 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.42 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	0.6 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E)	Thymol	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Sorbitol (UNII: 506T60A25R)
Poloxamer 407 (UNII: TUF2IVW3M2)
Benzoic Acid (UNII: 8SKN0B0MIM)
Zinc Chloride (UNII: 86Q357L16B)
Sodium Benzoate (UNII: OJ245FE5EU)
Sucralose (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0604-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2020
2	NDC: 69968-0604-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2020
3	NDC: 69968-0604-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/06/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)