Orajel JoJo Siwa: Package Insert and Label Information

ORAJEL JOJO SIWA- sodium fluoride paste, 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.

Active ingredient

Sodium fluoride 0.24%

Purpose

Anticavity toothpaste

Use

aids in the prevention of dental decay

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.

Keep out of reach of children

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

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

Principal Display Panel

Mixed Berry

Orajel Kids

Anticavity

Fluoride

Toothpaste

JoJo Siwa

LIVE YOUR

DREAM!

nickelodeon

NET WT

4.2 OZ

(119 g)

OJFC-99890-01 Toothpaste
(click image for full-size original)

KID’S

Spinbrush

+

Orajel kids

nickelodeon

INCLUDES

MYSTERY

JOJO BOW

JoJo Siwa

LIVE YOUR

DREAM!

Combo Pack Contents:

One Powered Toothbrush

One Fluoride Toothpaste

Net Wt. 4.2oz (119 g)

One Authentic JoJo Bow

OJFC-99890-01 Combo Pack
(click image for full-size original)
ORAJEL JOJO SIWA
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-794
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HYDRATED SILICA
METHYL SALICYLATE
CARBOXYMETHYLCELLULOSE SODIUM
SACCHARIN SODIUM (SACCHARIN)
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
SORBITOL
WATER
POLYETHYLENE GLYCOL 400
Product Characteristics
Color Score
Shape Size
Flavor BERRY (Mixed Berry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-794-42 1 TUBE in 1 BOX contains a TUBE
1 119 g in 1 TUBE This package is contained within the BOX (10237-794-42)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/01/2020
Labeler — Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture (10237-794)

Revised: 10/2020 Church & Dwight Co., Inc.

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