Label: ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO- sodium fluoride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • Active ingredient

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

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  • Purpose

    Anticavity  

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  • Use

    • aids in the prevention of dental cavities
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  • Warnings

    Keep out of reach of children.

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

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  • Directions

    adults and children 6 years of age and older:

    • use once a day after brushing your teeth with a toothpaste
    • remove cap
    • hold bottle upright and squeeze. Fill to FILL LINE
    • pour out. Only the correct 10 milliliters dose will pour out
    • vigorously swish 10 milliliters 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.

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  • Other Information

    • contains FD&C yellow no.5 (tartrazine) as a color additive
    • do not use if safety seal is broken or missing
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  • Inactive ingredients

    calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

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  • Principal Display Panel

    ACT Kids
    Anticavity Fluoride Rinse
    Scooby-Doo! Kiwi Watermelon
    Sodium Fluoride 0.05%
    16.9 fl oz (500 mL)

    ACT  Kids
Anticavity Fluoride Rinse
 Scooby-Doo! Kiwi Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)

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  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE RINSE KIDS SCOOBY DOO 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0934
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE CALCIUM DISODIUM ANHYDROUS  
    CETYLPYRIDINIUM CHLORIDE  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C GREEN NO. 3  
    POLOXAMER 407  
    POLYSORBATE 20  
    POTASSIUM SORBATE  
    PROPYLENE GLYCOL  
    SODIUM BENZOATE  
    SODIUM PHOSPHATE  
    SORBITOL  
    SUCRALOSE  
    WATER  
    FD&C YELLOW NO. 5  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor KIWI Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0934-0 500 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 12/01/2012
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 3 832973031 ANALYSIS(41167-0934), LABEL(41167-0934), MANUFACTURE(41167-0934), PACK(41167-0934), RECOVERY(41167-0934), RELABEL(41167-0934), REPACK(41167-0934)
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