Medication Guide App

Arm and Hammer Orajel Sensitive Freshening with Flavor Burst

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g, POTASSIUM NITRATE 50mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-661

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.

DRUG FACTS

Active ingredients        
Potassium nitrate 5.0%
Sodium fluoride 0.243%

Purpose

Antihypersensitivity
Anticavity toothpaste

Use 

  • aids in the prevention of dental decay
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

      

Warnings
When using this product
do not use longer than 4 weeks unless recommended by a dentist or physician.

Stop use and ask a dentist if the problem persists or worsens.  Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions    do not swallow   

adults and children 12 years and older

  • apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth for at least one minute, preferable after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician.  Make sure to brush all sensitive areas of the teeth.

children under 12 years

  • consult a dentist or physician

Inactive ingredients   sodium bicarbonate (baking soda), water, sorbitol, glycerin, hydrated silica, flavor, sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, cellulose gum, titanium dioxide, xanthan gum

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com

Principal Display Panel

ARM AND HAMMER ORAJEL SENSITIVE  FRESHENING WITH FLAVOR BURST
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-661
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE 
WATER 
SORBITOL 
GLYCERIN 
HYDRATED SILICA 
SACCHARIN SODIUM DIHYDRATE 
SODIUM LAURYL SULFATE 
SODIUM LAUROYL SARCOSINATE 
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
XANTHAN GUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Frosted Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-661-451 TUBE (TUBE) in 1 CARTON
1127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/29/2012
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture(10237-661)

Revised: 07/2013
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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