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SPL v6
SPL
SPL Set ID e80a7eea-5de6-4096-b8b1-036afb38572c
Route
DENTAL
Published
Effective Date 2023-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water Glycerin Xylitol Sodium Phosphate, Monobasic, Anhydrous Poloxamer 407 Phosphoric Acid Potassium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-07-01 Until 2026-09-30
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental cavities.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. 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 once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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
Questions?

1-855-444-3556

Active Ingredient

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

Other Information
  • store at room temperature
  • do not use if printed band around cap is broken or missing
Inactive Ingredients

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, phosphoric acid, potassium citrate.

Principal Display Panel 473 Ml Bottle Label

naturally

friendly™

hello®

ADA

Accepted

American

Dental

Association ®

kids fluoride rinse

anticavity + no alcohol

wild strawberry

natural flavor

rinses away stuff brushing misses.

prevents cavities.

tastes awesome.

16 FL OZ (1 PT) 473 mL

44949

Structured Label Content

Use

aids in the prevention of dental cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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
Questions?

1-855-444-3556

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • store at room temperature
  • do not use if printed band around cap is broken or missing
Inactive Ingredients (Inactive ingredients)

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, phosphoric acid, potassium citrate.

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

naturally

friendly™

hello®

ADA

Accepted

American

Dental

Association ®

kids fluoride rinse

anticavity + no alcohol

wild strawberry

natural flavor

rinses away stuff brushing misses.

prevents cavities.

tastes awesome.

16 FL OZ (1 PT) 473 mL

44949

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.314828 · Updated: 2026-03-14T23:07:36.685051