Fluoride Mouth Rinse Anticavity Mouthwash
FDA Label NDC 11673-213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Fluoride Mouth Rinse Anticavity (NDC 11673-213). 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, seek 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 the 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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 childrenas necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Other Information

store at room temperature

Inactive Ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Other

The ADA Council on Scientific Affairs Acceptance of up & up mint anticativity fluoride rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act

Dist. by Target Corp., Mpls., MN 55403

Made in U.S.A. with U.S. and foretign components

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213.002/213AE rev 2

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SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ANTICAVITY

fluoride mouthrinse

*Compare to Act Anticavity Fluoride Rinse

helps prevent cavities

helps strengthen teeth

freshens breath

up & up

Mint Flavor

IMPORTANT: read directions for proper use

18 fl oz (532 mL)

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Image Description (Mm1)

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