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

Antiseptic Blue Mint Mouthwash by

Drug Labeling and Warnings

Antiseptic Blue Mint Mouthwash by is a Otc medication manufactured, distributed, or labeled by Fore Supply, Inc, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 USE if 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 dentist if 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	06/05/2017

Labeler - Fore Supply, Inc (025126459)

Registrant - Fore Supply, Inc (025126459)

Establishment
Name	Address	ID/FEI	Business Operations
HealthSpecialty		794053863	MANUFACTURE(71627-128)