kids kare - toothpaste

kids kare - toothpaste
SPL v3
SPL
SPL Set ID 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca
Routes
dental oral
Published
Effective Date 2018-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (2.4 mg)
Inactive Ingredients
methylparaben sorbitol propylparaben polyethylene glycol 1450 hydrated silica sodium lauryl sulfate carboxymethylcellulose berry polyethylene glycol 300 water fd&c blue no. 1 saccharin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-10-26
Purpose

Anticavity toothpaste

Description

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Medication Information

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity toothpaste

Directions
  • Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
  • Children under 2 years of age: Consult a dentist or doctor.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6.
  • Instruct children under 6 years of age in good brushing and rinsing habits.
  • Supervise children as necessary until capable of using without supervision.
Other Information

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Description

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Principal Display Panel

kids kare™

Preventative

Treatment

0.24% Sodium Fluoride

Toothpaste

Berry Flavor

IMPORTANT:

Read directions carefully

Net Wt. 4 oz. (113.4 g)

Section 50565-1

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

Active Ingredient

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Questions Or Comments?

Call 1-800-752-2564

Structured Label Content

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity toothpaste

Directions
  • Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
  • Children under 2 years of age: Consult a dentist or doctor.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6.
  • Instruct children under 6 years of age in good brushing and rinsing habits.
  • Supervise children as necessary until capable of using without supervision.
Other Information (Other information)

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Principal Display Panel

kids kare™

Preventative

Treatment

0.24% Sodium Fluoride

Toothpaste

Berry Flavor

IMPORTANT:

Read directions carefully

Net Wt. 4 oz. (113.4 g)

Section 50565-1 (50565-1)

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

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Questions Or Comments? (Questions or comments?)

Call 1-800-752-2564

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.111641 · Updated: 2026-03-14T23:06:36.654428