Label: SENSITIVE WHITENING WITH BAKING SODA- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated September 30, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients        
    Potassium nitrate 5.0%
    Sodium fluoride 0.243%

  • PURPOSE

    Purpose
    Antihypersensitivity

    Anticavity toothpaste

  • INDICATIONS & USAGE

    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

    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

    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.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    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

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

  • Principal Display Panel


    ARM AND HAMMER The Standard of Purity

    Fluoride Anti-Cavity ToothpasteFrosted Mint Flavor

    Sensitive From the Makers of

    Orajel

    Maximum Relief Without a Prescription

    NET WT.

    4.5 OZ. (127g) Whitening with Baking Soda

    Carton image Carton image

  • INGREDIENTS AND APPEARANCE
    SENSITIVE  WHITENING WITH BAKING SODA
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-660
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Frosted Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-660-451 in 1 CARTON05/01/201209/30/2019
    1127 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-660-091 in 1 CARTON05/01/201209/30/2019
    225 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/29/2012
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-660)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!