ORAJEL FLUORIDE- sodium fluoride gel, dentifrice

Orajel Fluoride by

Drug Labeling and Warnings

Orajel Fluoride 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

Use aids in the prevention of dental decay

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

INACTIVE INGREDIENT

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

QUESTIONS

Questions or 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 Divine

Orajel ™

Anticavity

Fluoride

Toothpaste

Shimmer and Shine

NET WT. 4.2 OZ (119g)

Nickelodeon

INGREDIENTS AND APPEARANCE

ORAJEL FLUORIDE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-763
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-763-42	119 g in 1 TUBE; Type 0: Not a Combination Product	12/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/10/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-763)