OTC Medication Information: Antiseptic

ANTISEPTIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Shopko Operating Co., LLC

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.

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 imediately. 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

This product is not manufactured or distributed by Johnson & Johnmson Healthcare Products, distributor of Original Listerine

Adverse Reaction

Manufactured by Vi-Jon, Inc.,

One Swan Dr., Smyrna TN 37167

2012 ShopKo Stores Operating Co., LLC

www. shopko.com

For consumer questions

call 1-888-593 0593

principal display panel

Shopko

COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

Antiseptic

Mouth

Rinse

Original

Kills Germs That Cause Bad Breath, Plaque & The Gum Disease Gingivitis

1.5 Liters (50.7 FL OZ)

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ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-318
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
ALCOHOL
BENZOIC ACID
POLOXAMER 407
SODIUM BENZOATE
CARAMEL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37012-318-86 1000 mL in 1 BOTTLE, PLASTIC None
2 NDC:37012-318-12 1500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/09/1991
Labeler — Shopko Operating Co., LLC (023252638)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (37012-318)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (37012-318)

Revised: 06/2023 Shopko Operating Co., LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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