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Orajel

Church & Dwight Co., Inc.

Orajel Anticavity Fluoride Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient

Sodium fluoride (0.24%)


Purpose

Purpose

Anticavity toothpaste

Uses

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

Tube image OJTU-32024-01

Fintastic Fruit

2 plus years Kids

Orajel

Anticavity Fluroide
Toothpaste


NEW WT 4.2 OZ (119g)

Tube image

Orajel

Orajel

Sodium Fluoride GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10237-727
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.4 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
HYDRATED SILICA
polyethylene glycol 400
CARBOXYMETHYLCELLULOSE SODIUM
saccharin sodium
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1

Product Characteristics

Color
blue

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10237-727-42 119 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2014-01-01


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