Label: ENAMEL DEFENSE- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-666-09, 10237-666-43
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 19, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Sodium Fluoride 0.24%

  • PURPOSE

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental decay

  • WARNINGS

    Warnings

    Do not use if irritation occurs and persists.

  • KEEP OUT OF REACH OF CHILDREN

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

    If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not swallow
    • supervise children as necessary until capable of using without supervision
    • rinse away toothpaste residue thoroughly after brushing

    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

  • INACTIVE INGREDIENT

    sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, calcium sulfate, sodium lauryl sulfate, sodium saccharin, flavor, dipotassium phosphate, PEG/PPG 116/66 copolymer, sodium carbonate, calcium peroxide, mica, titanium dioxide

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ARM & HAMMER

    THE STANDARD OF PURITY

    Enamel Defense

    Fluoride Anticavity Toothpaste

    formerly known as BRIGHT & STRONG

    REPAIRS AND PROTECTS ENAMEL SURFACE

    Crisp Mint

    NET WT 4.3 OZ. (121g)

    LO_S01686C_2048783_R6

  • INGREDIENTS AND APPEARANCE
    ENAMEL DEFENSE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-666
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MICA (UNII: V8A1AW0880)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Crisp Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-666-431 in 1 CARTON04/01/2020
    1121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-666-091 in 1 CARTON04/01/2020
    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 finalpart35504/01/2020
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-666)
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!