Orajel Mermaid And Unicorn Fluoride Toothpaste

Orajel Mermaid And Unicorn Fluoride Toothpaste
SPL v6
SPL
SPL Set ID 99d62125-c2c5-5926-e053-2995a90aaa29
Route
DENTAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Glycerin Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Stevia Rebaudiana Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01
Description

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Warnings and Precautions

Warnings

Purpose

Anticavity

Description

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Use

aids in the prevention of dental decay

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.

Section 60561-8

Tamper Evident: Do not use if inner foil is torn, cut or missing.

Directions
  • twist off cap and remove foil seal
  • do not swallow
  • supervise children as necessary until capable of using without supervision
adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years ask a dentist of physician

Active Ingredient

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

Inactive Ingredients

sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, Stevia rebaudiana leaf extract, natural flavor

Questions Or Comments?

Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com

Principal Display Panel

NATURAL STRAWBERRY

magical unicorns OR mermaid

Orajel kids

Anti•cavity

TOOTHPASTE

Fluoride

NET WT 4.2 OZ (119 g)

Structured Label Content

Use

aids in the prevention of dental decay

Warnings and Precautions (34071-1)

Warnings

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.

Section 60561-8 (60561-8)

Tamper Evident: Do not use if inner foil is torn, cut or missing.

Purpose

Anticavity

Directions
  • twist off cap and remove foil seal
  • do not swallow
  • supervise children as necessary until capable of using without supervision
adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years ask a dentist of physician

Active Ingredient (Active ingredient)

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, Stevia rebaudiana leaf extract, natural flavor

Questions Or Comments? (Questions or comments?)

Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com

Principal Display Panel

NATURAL STRAWBERRY

magical unicorns OR mermaid

Orajel kids

Anti•cavity

TOOTHPASTE

Fluoride

NET WT 4.2 OZ (119 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:38.668599 · Updated: 2026-03-14T23:11:19.831195