Antispetic Mouthwash
FDA Label NDC 57243-664

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales Inc. for the product Antispetic (NDC 57243-664). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings for this product, do not use, stop use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help control plaque that leads to gingivitis

Warnings For This Product

Warnings

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

  • do not swallow
  • not intended to replace brushing or flossing
    • 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

Inactive Ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Other Information

Store at room temperture (59⁰- 77⁰ F)

Adverse Reactions

Distributed By

Salado Sales, Inc.

Temple, TX 76503

saladosales.com664.001/664AS

Principal Display Panel

CVP

ANTISEPTIC

MOUTH RINSE

BLUE MINT

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND GINGIVITIS GUM DISEASE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA

Accepted

American

Dental

Association

"The ADA Council on Scientific Affairs' Acceptance of CVP Blue Mint 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."

250 mL (8.5 FL OZ)  

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Image Description (Mm3)

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