ORAJEL ANTICAVITY- sodium fluoride gel, dentifrice
Church & Dwight Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Orajel Anticavity Fluoride Toothpaste

Active ingredient

Sodium fluoride (0.24%)

Purpose

Anticavity toothpaste

Use aids in the prevention of dental decay

Warnings

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

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

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

Question or comments Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

Bubble Berry

Orajel

Anticavity Fluroide

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PAW PATROL

NEW WT 4.2 OZ (119g)

OJTU-32024-04

ORAJEL ANTICAVITY
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10237-727
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg in 1 g

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

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT (Fin-tastic Fruit)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10237-727-42	119 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2014	08/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2014	08/07/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Church & Dwight Co., Inc.		043690812	manufacture(10237-727)

Revised: 8/2020

Document Id: ac4e6130-6250-fc7c-e053-2a95a90a77fd

Set id: ca7db40a-83c3-44ce-976e-d9cb13a8e33c

Version: 4

Effective Time: 20200807

Church & Dwight Co., Inc.