Aqua Blue Mouthwash

Aqua Blue Mouthwash
SPL v1
SPL
SPL Set ID e4ddfdfd-e389-4b36-af84-755bc544505a
Route
ORAL
Published
Effective Date 2020-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.6 mg) Menthol, Unspecified Form (0.42 mg) Eucalyptol (0.92 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Benzoic Acid Saccharin Sodium Sodium Benzoate Polysorbate 80 Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

helps control plaque that leads to gingivitis

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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

Section 50570-1

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.

Section 55105-1
Active ingredient Purpose
Eucalyptol 0.092% Antiplaque/Antigingivitis
Menthol 0.042% Antiplaque/Antigingivitis
Methyl Salicylate 0.060% Antiplaque/Antigingivitis
Thymol 0.064% Antiplaque/Antigingivitis
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.)


Structured Label Content

Use

helps control plaque that leads to gingivitis

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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.

Section 55105-1 (55105-1)
Active ingredient Purpose
Eucalyptol 0.092% Antiplaque/Antigingivitis
Menthol 0.042% Antiplaque/Antigingivitis
Methyl Salicylate 0.060% Antiplaque/Antigingivitis
Thymol 0.064% Antiplaque/Antigingivitis
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 (Other information)

Store at room temperature (59°-77°F).

Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label)

BodyOne

Products

AQUA ⚬ BLUE

MOUTH WASH

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


Advanced Ingredient Data


Raw Label Data

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