Soft Mint Listerine Antiseptic [250 ml, 500 ml, 1 L, 1.5 L]

Drug Labeling and Warnings

Drug Details [pdf]

SOFT MINT LISTERINE  ANTISEPTIC- eucalyptol, menthol, 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.

----------

Soft Mint
Listerine Antiseptic
[250 ml, 500 ml, 1 L, 1.5 L]

Drug Facts

Active ingredientsPurposes
Eucalyptol 0.092%Antiplaque/antigingivitis
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%

Uses

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 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.

Inactive ingredients

water, alcohol (21.6%), sorbitol solution, poloxamer 407, flavor, benzoic acid, sucralose, sodium benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no. 1

Questions?

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

PRINCIPAL DISPLAY PANEL - 1.5 Liter Bottle Label

LISTERINE®
SOFT MINT®

ANTISEPTIC

Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis

ADA
Accepted
American
Dental Association

1.5L (1 Qt 1 Pt 2.7 Fl OZ)

PRINCIPAL DISPLAY PANEL - 1.5 Liter Bottle Label
SOFT MINT LISTERINE   ANTISEPTIC
eucalyptol, menthol, methyl salicylate and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-404
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate0.6 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E) Thymol0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Sorbitol (UNII: 506T60A25R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Sucralose (UNII: 96K6UQ3ZD4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Propylene Glycol Alginate (UNII: 26CD3J2R0C)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-404-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/201012/26/2011
2NDC: 42002-404-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/201004/20/2014
3NDC: 42002-404-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/201005/19/2016
4NDC: 42002-404-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/201011/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/05/201011/17/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2019
Document Id: b7a10db0-df8c-4a5b-8cbe-10349f6e0b2f
Set id: 9509e548-3a0b-421e-a87d-a7af0f9438a6
Version: 3
Effective Time: 20190926