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NDC 11822-0664-01 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 Rite Aid. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	11822-0664
Product ID	11822-0664_bac9a8a4-bb4b-43ab-b41b-2b107c88833e
Associated GPIs	46100030102750
GCN Sequence Number	003022
GCN Sequence Number Description	magnesium sulfate GRANULES 495 MG/5 G ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09200
HICL Sequence Number	001327
HICL Sequence Number Description	MAGNESIUM SULFATE
Brand/Generic	Generic
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	Rite Aid
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 11822-0664-01 (11822066401)

Pricing Information	N/A
NDC Package Code	11822-0664-1
Billing NDC	11822066401
Package	1000 mL in 1 BOTTLE, PLASTIC (11822-0664-1)
Marketing Start Date	1995-07-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d55d4101-be0c-47d9-a2ad-d3d30516bf04 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 infromation

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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, FD&C green no.3

ADA council Statement

The ADA council on Scientific Affairs Acceptance of Rite Aid Blue Mint Antiseptic Mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine

Adverse Reactions

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane, Camp Hill, PA 17011

www. riteaid.com

SATISFACTION GUARANTEE

If you are not satisfied, we'll happily refund your money

principal display panel

Sealed with printed neckband for your protection

Compare to Cool Mint Listerine

Antiseptic Mouthwash

ANTISEPTIC

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE MOUTH RINSE

BLUE MINT

help reduce plaque & gingivitis

fights bad breath

child-resistant cap

RITE

AID

PHARMACY

3.2 FL OZ (94 mL)

INGREDIENTS AND APPEARANCE

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0664
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:11822-0664-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995
2	NDC:11822-0664-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995
3	NDC:11822-0664-3	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995
4	NDC:11822-0664-4	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995
5	NDC:11822-0664-5	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995
6	NDC:11822-0664-7	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/1995

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/21/1995

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11822-0664)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11822-0664)

Revised: 5/2022

Document Id: bac9a8a4-bb4b-43ab-b41b-2b107c88833e

Set id: d55d4101-be0c-47d9-a2ad-d3d30516bf04

Version: 11

Effective Time: 20220519