Label: HELLO WILD STRAWBERRY- sodium fluoride mouthwash

  • NDC Code(s): 35000-685-10
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 21, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years of age and older:

    • use once a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor
  • Other information

    • store at room temperature
    • do not use if printed band around cap is broken or missing
  • Inactive ingredients

    purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, phosphoric acid, potassium citrate.

  • Questions?

    1-855-444-3556

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products
    LLC Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    naturally
    friendly™
    hello®

    ADA
    Accepted
    American
    Dental
    Association ®

    kids fluoride rinse
    anticavity + no alcohol

    wild strawberry
    natural flavor

    rinses away stuff brushing misses.

    prevents cavities.

    tastes awesome.

    16 FL OZ (1 PT) 473 mL

    44949

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HELLO WILD STRAWBERRY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-685
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-685-10473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02107/01/2023
    Labeler - Colgate-Palmolive Company (001344381)
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