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NDC 50804-0072-86 Antiseptic Mouth Rinse .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Antiseptic Mouth Rinse .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Antiseptic Mouth Rinse is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, INC.. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	50804-0072
Product ID	50804-072_27323458-1f5d-4c4f-ba47-bc5ad11ef92f
Associated GPIs	88300000000900
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	Antiseptic Mouth Rinse
Proprietary Name Suffix	n/a
Non-Proprietary Name	EUCALYPTOL
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	.92; .42; .6; .64
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Labeler Name	Perrigo Direct, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0072-86 (50804007286)

Pricing Information	N/A
NDC Package Code	50804-072-86
Billing NDC	50804007286
Package	1000 mL in 1 BOTTLE, PLASTIC (50804-072-86)
Marketing Start Date	2009-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 790843ce-88e2-4060-b61f-925fb30272da Details

Active Ingredients

Eucalyptol 0.092%, Menthol 0.042%

Methyl salicylate 0.060%, Thymol 0.064%

Purpose

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Do not use

if you have painful or swollen gums, pus from the gum line, loose teeth or

increased spacing between the teeth. See you dentist immediately.These may be signs

of periodontitis, 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 older -

Vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

Children under 12 years of age -

Consult a dentist or doctor

This 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 (59⁰ - 77⁰ F)

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

1-888-593-0593

GoodSense is a registered trademark of L. Perrigo Company

DSP-TN-21091

DSP-MO-20087

Principal Panel Display

Sealed With Printed Neckband For your Protection

GoodSense

NDC 50804-072-86

ANTISEPTIC MOUTH RINSE

Spring Mint

ADA Accepted

American Dental Association

Helps prevent and reduce plaque
Helps prevent and reduce gingivitis

Kills germs that cause bad breath, plaque & the gum disease gingivitis

Compare to the Active Ingredients in Listerine*

1 LITER (33.8 FLOZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE

eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-072
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 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)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/2009
2	NDC:50804-072-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/15/2009

Labeler - Perrigo Direct, INC. (076059836)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(50804-072)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		088520668	manufacture(50804-072)

Revised: 10/2022

Document Id: 27323458-1f5d-4c4f-ba47-bc5ad11ef92f

Set id: 790843ce-88e2-4060-b61f-925fb30272da

Version: 5

Effective Time: 20221003