Label: PEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-655-12, 10237-655-60, 10237-655-72
  • 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 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients        
    Sodium fluoride (0.24%)

  • PURPOSE

    Purpose
    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use    aids in the prevention of dental decay   

  • KEEP OUT OF REACH OF CHILDREN

    Warning

    Do not use if irritation occurs and persists.
    _________________________________________________

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


  • WARNINGS

    Warnings

    Do not use if irritation occurs and persists.

    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    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 throughly 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                                    consult a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients   sodium bicarbonate (baking soda), PEG-8, PEG/PPG-116/66 copolymer, sodium carbonate peroxide, tetrasodium pyrophosphate, silica, sodium saccharin, flavor, water, sodium lauryl sulfate, sodium lauroyl sarcosinate.

  • 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

    Clean Mint Naturally Powered By Baking Soda Fluoride Anticavity Toothpaste

    PeroxiCare

    Deep Clean

    Baking Soda and Peroxide Healthy Gums Neutralizes Acid

    NET WT. 6.0 OZ. (170g)

    DA2008558_PCFC-18770-08

  • INGREDIENTS AND APPEARANCE
    PEROXIE CARE TARTAR CONTROL  HEALTHY GUMS BAKING SODA AND PEROXIDE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-655
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Fresh Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-655-601 in 1 CARTON01/29/2012
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-655-721 in 1 CARTON01/29/201210/07/2019
    2204 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10237-655-122 in 1 CARTON01/29/2012
    3340 g in 1 TUBE; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-655)
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