ORAJEL KIDSTOOTHPASTE- sodium fluoride paste, dentifrice

Orajel KidsToothpaste by

Drug Labeling and Warnings

Orajel KidsToothpaste 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

Use

aids in the prevention of dental decay

Warnings

Warnings

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 of physician

Inactive ingredients

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

Questions or comments?

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

Warnings

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.

Principal Display Panel

Mixed Berry

Orajel

Anticavity

Fluoride

Toothpaste

magical unicorns OR mermaid

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

ORAJEL KIDSTOOTHPASTE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-785
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
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-785-42	119 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-785)