ORAL CARE ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Oral Care Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

TEP

Sealed With Printed Neckband For Your Protection

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

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

0ther information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADA Council Statement

“The ADA Council on Scientific Affairs’ Acceptance of Rite Aid Original 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 Reaction

DISTRIBUTED BY:

RITE AID

30 Hunter Lane, Camp Hill, PA 17011

SATISFACTION

GUARANTEE

Learn more at

www.RiteAid.com

DSP-TN-15000

DSP-MO-34

SDS-TN15012

318.003/318AH

Principal Display Panel

RITE

AID

PHARMACY

COMPARE TO THE

ACTIVE INGREDIENTS IN lISTERINE

oral care

antiseptic

mouth rinse

original

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

ORAL CARE ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3108
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3108-2	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/1990
2	NDC: 11822-3108-0	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/15/1990

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(11822-3108)