Orajel™

Orajel™
SPL v1
SPL
SPL Set ID cd47bd1e-44ac-465f-8529-6073ade14706
Route
ORAL
Published
Effective Date 2024-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Glycerin Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Stevia Rebaudiuna Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental decay

Section 42229-5

Drug Facts

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.

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
Active Ingredient

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

Inactive Ingredients

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)".

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 119 G Tube Label

DREAMWORKS

GABBY'S

DOLLHOUSE

STAGE

2

0-3

YEARS

Orajel

kids

NATURALLY

SOURCED*

anti • cavity

TOOTHPASTE

fluoride

NATURAL

FRUITY

BUBBLE

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)


Structured Label Content

Use

aids in the prevention of dental decay

Section 42229-5 (42229-5)

Drug Facts

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.

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 or physician
Active Ingredient

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

Inactive Ingredients (Inactive ingredients)

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)".

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 119 G Tube Label (PRINCIPAL DISPLAY PANEL - 119 g Tube Label)

DREAMWORKS

GABBY'S

DOLLHOUSE

STAGE

2

0-3

YEARS

Orajel

kids

NATURALLY

SOURCED*

anti • cavity

TOOTHPASTE

fluoride

NATURAL

FRUITY

BUBBLE

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)