Orajel Paw Patrol Anticavity Fluoride Toothpaste

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.5 mg)

Inactive Ingredients

Hydrated Silica Methyl Salicylate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Sodium Lauryl Sulfate Fd&c Blue No. 1 Sorbitol Water Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-11-01

Medication Information

Warnings and Precautions

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.

Indications and Usage

aids in the prevention of dental decay

Dosage and Administration

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 or physician

Description

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

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 51727-6

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Natural Flavor, Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia). All inactive ingredients are described in the format "ingredient name (source)".

Section 51945-4

nickelodeon™

PAW

PATROL

STAGE

3

2-10 YEARS

Orajel™

kids

NATURALLY

SOURCED*

anti · cavity

TOOTHPASTE

fluoride

NATURAL

FRUITY

BUBBLE

NET WT 4.2 OZ (119 g)

Section 55105-1

Anticavity toothpaste

Section 55106-9

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 www.orajelkids.com

Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of dental decay

Dosage and Administration (34068-7)

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 or physician

Warnings and Precautions (34071-1)

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 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 51727-6 (51727-6)

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Natural Flavor, Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia). All inactive ingredients are described in the format "ingredient name (source)".

Section 51945-4 (51945-4)

nickelodeon™

PAW

PATROL

STAGE

3

2-10 YEARS

Orajel™

kids

NATURALLY

SOURCED*

anti · cavity

TOOTHPASTE

fluoride

NATURAL

FRUITY

BUBBLE

NET WT 4.2 OZ (119 g)

Section 55105-1 (55105-1)

Anticavity toothpaste

Section 55106-9 (55106-9)

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 www.orajelkids.com

Advanced Ingredient Data

[{"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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)

{"34067-9": "aids in the prevention of dental decay", "34068-7": "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 or physician", "34071-1": "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.", "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.", "51727-6": "Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Natural Flavor, Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia). All inactive ingredients are described in the format "ingredient name (source)".", "51945-4": "nickelodeon™ PAW PATROL STAGE 3 2-10 YEARS Orajel™ kids NATURALLY SOURCED* anti · cavity TOOTHPASTE fluoride NATURAL FRUITY BUBBLE NET WT 4.2 OZ (119 g)", "55105-1": "Anticavity toothpaste", "55106-9": "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 www.orajelkids.com"}

Orajel Paw Patrol Anticavity Fluoride Toothpaste

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information