Anticavity Rinse
FDA Label NDC 55910-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Anticavity (NDC 55910-030). 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 ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

Warnings

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 year of age: consult a dentist or doctor

Other Information

  • store at room temperture

Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other

Sealed with printed neckband for your protection

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.

DISTRIBUTED BY Old East Main CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888) 309-9030

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DG health

Compare to Act Bubblegum Blowout

Anticavity Kids Fluoride Rinse

KIDS

Anticavity Fluoride Rinse

Strong Cavity Protection

Helps Strengthen Teeth

Alcohol Free

IMPORTANT: Read directions for proper use

Bubblegum Flavor

16.9 FL OZ

(500 mL)

Image Description (Mm1)

Image Description (Mm1)

Since 1903

Rexall

kids

Anticavity

Fluoride Rinse

Anticavitvy Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • Alcohol free

    • IMPORTANT: read directions for proper use.

    Bubblegum Flavor

    500 mL (1 PT 0.9 FL OZ) 16.9 FL OZ

    Image Description (Mm3)

    Image Description (Mm3)

* Please review the disclaimer below.