Anticavity Rinse
FDA Label NDC 55910-971

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 55910-971). 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, warning, 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 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

for this product

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute and 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 years of age: consult a dentist or doctor

Other Information

  • store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive Ingredients

water, sorbitol, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

Other

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

This product isnot intended to replace brushing or flossing

100% Satisfaction Guaranteed

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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