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NDC 50804-0664-69 Antispetic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Antispetic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Antispetic 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	50804-0664
Product ID	50804-664_cc391ee3-a7d3-43e4-b6e4-c0f94ca7745a
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	Antispetic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eucalyptol, menthol, methyl salicylate, thymol
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	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0664-69 (50804066469)

Pricing Information	N/A
NDC Package Code	50804-664-69
Billing NDC	50804066469
Package	250 mL in 1 BOTTLE, PLASTIC (50804-664-69)
Marketing Start Date	1992-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cb4cf304-4f19-40cd-b480-9d89d1909684 Details

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

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 your 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 (59°-77°F).

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.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

www.PerrigoDirect.com

1-888-593-0593

Good Sense is a registered trademark of L. Perrigo Company.

DSP-TN21091

DSP-MO20087

Principal Panel Display

Sealed With Printed Neckband For Your Protection

GOODSENSE NDC 50804-664-12

Antiseptic Mouth Rinse

Blue 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 active ingrdients of Listerine*

1.5Liters

(50.7 FLOZ)

INGREDIENTS AND APPEARANCE

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-664
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	0.42 mg in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 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 BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-664-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/1992
2	NDC:50804-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/1992
3	NDC:50804-664-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/1992
4	NDC:50804-664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/1992

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	10/01/1992

Labeler - Perrigo Direct Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-664)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-664)

Revised: 10/2022

Document Id: cc391ee3-a7d3-43e4-b6e4-c0f94ca7745a

Set id: cb4cf304-4f19-40cd-b480-9d89d1909684

Version: 19

Effective Time: 20221003