AQUA BLUE MOUTHWASH- methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid 
Body One Products 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.

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Aqua Blue Mouthwash

Drug Facts

Active ingredientPurpose
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

Adults and children 12 years of age and olderVigorously swish 20mL between teeth twice a day for 30 seconds then spit out.
children under 12 years of ageconsult 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.)

PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label
AQUA BLUE MOUTHWASH 
methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73563-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate0.6 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 mg  in 1 mL
Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 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) 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
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73563-022-013785 mL in 1 JUG; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/01/2020
Labeler - Body One Products Inc (117376115)
Registrant - BMC 1092,Inc dba Solo Laboratories, Inc (078831987)
Establishment
NameAddressID/FEIBusiness Operations
BMC 1092,Inc dba Solo Laboratories, Inc078831987MANUFACTURE(73563-022)

Revised: 2/2020
Document Id: 0eb8ad36-cad6-457f-a1c9-9fa0c76b227e
Set id: e4ddfdfd-e389-4b36-af84-755bc544505a
Version: 1
Effective Time: 20200227
 
Body One Products Inc