Toms Childrens Anticavity Mouthwash Silly Strawberry Rinse
FDA Label NDC 51009-840

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tom's Of Maine, Inc. for the product Toms Childrens Anticavity Mouthwash Silly Strawberry (NDC 51009-840). 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 other, active ingredient (in each 10ml), purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by Tom's of Maine, Inc., Kennebunk, ME 04043 U.S.A.

Active Ingredient (In Each 10Ml)

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

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

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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

Inactive Ingredients

water, glycerin, Aloe barbadensis leaf juice

organic

, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Principal Display Panel - 473 Ml Bottle Label

New!

SINCE 1970
Tom's
OF MAINE®

alcohol-free | natural

children's anticavity

fluoride rinse

cavity protection for
a healthy smile

tastes great

dye free

silly
strawberry™

16 FL OZ (473 mL)

P9929760

IMPORTANT: Read
directions for proper use

Principal Display Panel (473 mL Bottle Label)

Principal Display Panel (473 mL Bottle Label)

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