ORIGINAL ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Duane Reade

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Duane Reade 318

TEP

Sealed with printed neckband for your protection

Active ingredient

Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%

Purpose

Antiginvitis, 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 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

DISTRIBUTED BY DUANE READE

(866)375-6925

440 NINETH AVE, NY,NY 10001

duanereade.com

318.003/318AH

principal display panel

UNIQUELY NY DR SINCE 1960

original

antiseptic mouthwash

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

1.5 LITERS (50.7 FL OZ)

image description

ORIGINAL ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67732-318
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67732-318-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992	07/13/2020
2	NDC:67732-318-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992	07/13/2020
3	NDC:67732-318-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992	07/13/2020
4	NDC:67732-318-69	.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992	07/13/2020
5	NDC:67732-318-13	1.2 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/1992	07/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/15/1992	07/13/2020

Labeler - Duane Reade (011988995)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(67732-318)

Revised: 7/2020

Document Id: 43ccea07-fce9-43d5-bae2-a26807ee399a

Set id: 71bf6b45-828b-4b73-8c64-3f846fee3166

Version: 4

Effective Time: 20200713

Duane Reade