Label: RON 2- sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly kit

  • 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 December 27, 2021

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  • COLGATE TOOTHPASTE

  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Warnings

    Keep out of the 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

     adults and children 2 years of age and older brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or physician
     children 2 to 6 years  use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
     children under 2 years ask a dentist or physician

  • Inactive ingredients

    dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavor), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • Dove advanced care cool essentials anti-perspirant deodorant

  • Drug Facts

  • Active ingredient

    Aluminum Zirconium Tetrachlorohydrex GLY (15.2%)

  • Purpose

    anti-perspirant

  • Uses

    • Reduces Underarm Wetness
    • 48 Hour Protection
  • Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have kidney disease.

    Stop use if rash or irritation occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to underarms only

  • Inactive ingredients

    Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, PEG-8, Fragrance (Parfum), Dimethicone, Silica, Polyethylene, Helianthus Annuus (Sunflower) Seed Oil, Steareth-100, BHT, Hydroxyethyl Urea

  • Questions or comments?

    Call toll free 1-800-761-3683

  • Package Labeling:

    product label

    drug facts panel

  • Package Labeling:

    frontbooklet

  • INGREDIENTS AND APPEARANCE
    RON 2 
    sodium monofluorophosphate, aluminum zirconium tetrachlorohydrex gly kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-030
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-030-001 in 1 BAG; Type 1: Convenience Kit of Co-Package03/30/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 10 g
    Part 21 TUBE 14 g
    Part 1 of 2
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:42555-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-060-4510 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/30/2015
    Part 2 of 2
    DOVE   ADVANCED CARE COOL ESSENTIALS ANTIPERSPIRANT AND DEODORANT
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Item Code (Source)NDC:64942-1343
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY15.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1343-314 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35003/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/30/2015
    Labeler - Buzz Export Services Pty., Ltd. (747317902)
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