d8008c90-77b2-4fa9-bb65-ad76734f26f6 — v16

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Version

v16

Effective date

September 30, 2025

Original packager

Sections captured

15

Identifiers

Document ID
4009799e-ae8c-1d64-e063-6394a90a269e
Set ID
d8008c90-77b2-4fa9-bb65-ad76734f26f6
Application numbers
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Original packager NDCs

Names & Manufacturers

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Substances & Pharmacology

Substance names
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Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
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Other identifiers

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RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

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Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%
Adverse Reactions (1)

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ADVERSE REACTION *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash Manufactured for Big Lots By Vi-Jon, LLC 8515 Page Avenue St. Louis, MO 63114 DSP-TN-15000 DSP-MO-34 SDS-TN-15012
Do Not Use (1)

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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.
Dosage And Administration (1)

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Directions adults and childen 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
Inactive Ingredient (1)

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Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&Cyellow 10, FD&C green 3
Indications And Usage (1)

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Use helps control plaque that leads to gingivitis
Keep Out Of Reach Of Children (1)

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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.
Other Safety Information (1)

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Tamper Evident Statement Sealed With Printed Neckband For Your Protection
Package Label Principal Display Panel (1)

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principal display panel SOUNDBODY™ Compare to active Ingredients in Freshburst Listerine Antiseptic* ANTISEPTIC MOUTHRINSE Antigingivitis/Antiplaque Kills Germs That Cause: Plaque Bad Breath Gingivitis Gum Disease SPRING MINT ® 1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ image description image description
Purpose (1)

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Purpose Antigingivitis, Antiplaque
Questions (1)

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Questions or comments? 1-888-593-0593
Spl Product Data Elements (1)

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Antispetic Eucalyptol, menthol, methyl salicylate, thymol WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM CITRATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL
Spl Unclassified Section (1)

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other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F).
Stop Use (1)

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Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.
Warnings (1)

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Warnings for this product