Orajel Anticavity Fluoride Toothpaste

Orajel Anticavity Fluoride Toothpaste
SPL v5
SPL
SPL Set ID 71713187-f51b-fcf1-e053-2995a90abe69
Route
DENTAL
Published
Effective Date 2022-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Sorbitol Sodium Lauryl Sulfate Fd&c Blue No. 1 Carboxymethylcellulose Sodium Polyethylene Glycol 400 Saccharin Hydrated Silica Water

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-07-20 Until 2025-11-14

Description

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


Medication Information

Warnings and Precautions

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

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.

Section 51727-6

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

Section 51945-4

JURASSIC WORLD

Stage

3

2-10 YEARS

Orajel™

kids

NATURALLY

SOURCED*

anti•cavity

TOOTHPASTE

fluoride

NATURAL

BERRY

BLAST

OUR

COMMITMENT

CERTIFIED RENEWABLE ENERGY

Green-e®

PROUD SUPPORTER OF

Arbor Day

Foundation®

PLASTIC

TUBE

how2recycle.info

SCAN ME

NET WT 4.2 OZ (119 g)

Section 53413-1

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

Section 55105-1

Anticavity

Section 55106-9

Sodium Fluoride (0.24%)

(0.15% w/v fluoride ion)

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 denist or physician


Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental decay

Warnings and Precautions (34071-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

JURASSIC WORLD

Stage

3

2-10 YEARS

Orajel™

kids

NATURALLY

SOURCED*

anti•cavity

TOOTHPASTE

fluoride

NATURAL

BERRY

BLAST

OUR

COMMITMENT

CERTIFIED RENEWABLE ENERGY

Green-e®

PROUD SUPPORTER OF

Arbor Day

Foundation®

PLASTIC

TUBE

how2recycle.info

SCAN ME

NET WT 4.2 OZ (119 g)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride (0.24%)

(0.15% w/v fluoride ion)

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 denist or physician


Advanced Ingredient Data


Raw Label Data

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