ANTISEPTIC BLUE MINT MOUTHWASH- methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid
Fore Supply, Inc

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Fore Supply (as PLD) - Antiseptic Blue Mint Mouthwash (71627-128) - DELIST

Active Ingredients	Purpose
Eucalyptol 0.092% , Menthol 0.04%	Antigingivitis , Antiplaque
Methyl Salicylate0.060%,Thymol,0.064%	Antigingivitis , Antiplaque

Use

Helps control plaque that leads to gingivitis

WARNINGS

DO NOT USEif you have painful or swollen gums, pus from the gum line,loose teeth or increased spacing between the teeth, see your dentist immediately, these may be a sign of periodontitis, as serious form of gum disease

Stop use and ask a dentistif gingivitis, bleeding or redness persists for more than 2 weeks.

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

Adults and children 12 years of age and older….vigously swish 20 ml between teeth for 30 seconds then spit out; do not swallow.

Children under 12 years of age…. Consult a dentist or doctor

*Rinse is not intended to replace brushing or flossing

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59 °– 77 °F)

Inactive Ingredients

Water, Alcohol 21.6%, Polysorbate 80,Sorbitol,Flavor, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Blue 1, Yellow 5

antiseptic-01

ANTISEPTIC BLUE MINT MOUTHWASH
methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71627-128
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)	216 mg in 1 mL
SORBITOL (UNII: 506T60A25R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71627-128-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/05/2017	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	06/05/2017	12/31/2023

Labeler - Fore Supply, Inc (025126459)

Revised: 4/2024

Document Id: 150fb675-6d98-0e74-e063-6394a90a4826

Set id: 50521f23-c81e-4073-b33c-393619db81fb

Version: 4

Effective Time: 20240401

Fore Supply, Inc