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NDC 73563-0022-01 Aqua Blue Mouthwash .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Aqua Blue Mouthwash .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Aqua Blue Mouthwash is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Body One Products Inc. The primary component is EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL.

Product Information

NDC	73563-0022
Product ID	73563-022_0eb8ad36-cad6-457f-a1c9-9fa0c76b227e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aqua Blue Mouthwash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate, Menthol, Unspecified Form, Eucalyptol, and Thymol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	.92; .42; .6; .64
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL
Labeler Name	Body One Products Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2022-12-31

Package

Package Images

NDC 73563-0022-01 (73563002201)

Pricing Information	N/A
NDC Package Code	73563-022-01
Billing NDC	73563002201
Package	3785 mL in 1 JUG (73563-022-01)
Marketing Start Date	2020-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e4ddfdfd-e389-4b36-af84-755bc544505a Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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.)

PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label

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

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:73563-022-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2020

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

Labeler - Body One Products Inc (117376115)

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

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

Revised: 2/2020

Document Id: 0eb8ad36-cad6-457f-a1c9-9fa0c76b227e

Set id: e4ddfdfd-e389-4b36-af84-755bc544505a

Version: 1

Effective Time: 20200227

Search by Drug Name or NDC

NDC 73563-0022-01 Aqua Blue Mouthwash .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Aqua Blue Mouthwash .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Product Information

Package

Package Images

NDC 73563-0022-01 (73563002201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e4ddfdfd-e389-4b36-af84-755bc544505a Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Use

Warnings

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label

INGREDIENTS AND APPEARANCE

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