Listerine Gum Therapy Antiseptic: Package Insert and Label Information

LISTERINE GUM THERAPY ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate and thymol mouthwash
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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)

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)

Principal Display Panel -- 1.0 L Bottle Label
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.6 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
ZINC CHLORIDE
SODIUM BENZOATE
SUCRALOSE
SACCHARIN SODIUM
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0604-5 500 mL in 1 BOTTLE, PLASTIC None
2 NDC:69968-0604-1 1000 mL in 1 BOTTLE, PLASTIC None
3 NDC:69968-0604-9 95 mL in 1 BOTTLE, PLASTIC None
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)

Revised: 09/2021 Johnson & Johnson Consumer Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.