ORAJEL- sodium fluoride gel, dentifrice

Orajel by

Drug Labeling and Warnings

Orajel by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride (0.24%)

PURPOSE

Anticavity Toothpaste

INDICATIONS & USAGE

Aids in the prevention of dental decay

WARNINGS

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

INSTRUCTIONS FOR USE

twist off cap and remove foil seal

do not swallow

supervise children as necessary until capable of using without supervision

DOSAGE & ADMINISTRATION

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 INGREDIENT

sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1

QUESTIONS

Questions of comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com

PRINCIPAL DISPLAY PANEL

Berry Blast

Orajel

Anticavity

Fluoride

Toothpaste

Jurassic World

NET WT 4.2 OZ (119g)

INGREDIENTS AND APPEARANCE

ORAJEL 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-775
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue (Berry)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-775-42	1 g in 1 TUBE; Type 0: Not a Combination Product	07/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/20/2018

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-775)