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

Aqua Blue Mouthwash by

Drug Labeling and Warnings

Aqua Blue Mouthwash by is a Otc medication manufactured, distributed, or labeled by Body One Products Inc, BMC 1092,Inc dba Solo Laboratories, 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 control plaque that leads to gingivitis

Warnings

Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontis, a 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

• do not swallow
• not intended to replace brushing or flossing.

• Adults and children 12 years of age and older: Vigorously swish 20mL between teeth twice a day for 30 seconds then spit out.
• children under 12 years of age: consult a dentist or doctor

Other information

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 - 128 FL.OZ. Jug Label

BodyOne
Products

AQUA ⚬ BLUE

MOUTH WASH

1 U.S. Gallon (128 FL.OZ.)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73563-022
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: 73563-022-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/01/2020

Labeler - Body One Products Inc (117376115)

Registrant - BMC 1092,Inc dba Solo Laboratories, Inc (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092,Inc dba Solo Laboratories, Inc		078831987	MANUFACTURE(73563-022)