orajel kids super mario anticavity toothpaste

orajel kids super mario anticavity toothpaste
SPL v2
SPL
SPL Set ID 27d2f6cb-8661-da9c-e063-6394a90a5bde
Route
oral
Published
Effective Date 2023-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (2.4 mg)
Inactive Ingredients
glycerin stevia rebaudiana leaf cellulose gum water sorbitol cocamidopropyl betaine hydrated silica

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-13

Purpose

Anticavity

Description

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


Medication Information

Purpose

Anticavity

Directions

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using wilhout 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

Inactive Ingredients

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural flavor.

All inactive ingredients are described in the format "ingredient name (source)".

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 51945-4

SUPER MARIO

STAGE 3

2-10 YEARS

ORAJEL TM KIDS

anti-cavity

TOOTHPASTE

fluoride

NATURALLY SOURCED*

NATURAL BERRY

NET WT 4.2 OZ (119 g)

Active Ingredient

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


Structured Label Content

Purpose (PURPOSE)

Anticavity

Directions (DIRECTIONS)

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using wilhout 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

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural flavor.

All inactive ingredients are described in the format "ingredient name (source)".

Use (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 51945-4 (51945-4)

SUPER MARIO

STAGE 3

2-10 YEARS

ORAJEL TM KIDS

anti-cavity

TOOTHPASTE

fluoride

NATURALLY SOURCED*

NATURAL BERRY

NET WT 4.2 OZ (119 g)

Active Ingredient (ACTIVE INGREDIENT)

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


Advanced Ingredient Data


Raw Label Data

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