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

Purpose

Anticavity

Description

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

Medication Information

Warnings and Precautions

Warnings

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

Inactive Ingredients

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

Description

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

Principal Display Panel

NATURAL STRAWBERRY

magical unicorns OR mermaid

Orajel kids

Anti•cavity

TOOTHPASTE

Fluoride

NET WT 4.2 OZ (119 g)

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.

Active Ingredient

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

Questions Or Comments?

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

NATURAL STRAWBERRY

magical unicorns OR mermaid

Orajel kids

Anti•cavity

TOOTHPASTE

Fluoride

NET WT 4.2 OZ (119 g)

Use

aids in the prevention of dental decay

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.

Active Ingredient (Active ingredient)

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

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

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIANA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental decay", "34071-1": "Warnings", "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.", "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": "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)"}

Additional Information

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