ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

Antiseptic Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (59⁰ - 77⁰F)

Inactive ingredients

water, alcohol 21.6%, sorbitol {solution}, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3

ADA staement

The ADA Council on Scientific Affairs Acceptance of Rite Aid Fresh Mint Antiseptic Mouth Rinse is based on it finding that the product is effective  in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed.

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

DSP-TN-15000, DSP-MO-34, SDS-TN-15012

Adverse reaction

DISTRIBUTED BY

Rite Aid

30 Hunter Lane, camp Hill, PA 17011

Learn more at www.RiteAid.com

072.002/072AA

Principal Display Panel

RITE

AID

PHARMACY

compare to the active ingredient in Listerine

oral care

antiseptic

mouth rinse

fresh mint

ADA

Accepted

American

Dental 

Association

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

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0072-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/1997

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11822-0072)