Label: WHITENING- yayashi whitening gel, dentifrice

  • NDC Code(s): 84727-051-01
  • Packager: Guangzhou Baishili Trading Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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

  • PURPOSE

    Emphasize that the toothpaste uses mild whitening ingredients that do not damage tooth enamel, is suitable for daily use, and helps users easily achieve teeth whitening effects

  • WARNINGS

    Warnings:

    For external use only: Do not ingest the toothpaste. If swallowed, seek medical help immediately.

    Avoid use on damaged or sensitive gums: If you have sensitive teeth, gums, or any oral health concerns, consult with a dentist before using this product.

    Possible sensitivity: Some individuals may experience mild tooth or gum sensitivity with whitening products. Discontinue use if sensitivity persists or worsens, and consult a dentist if necessary.

    Keep out of reach of children: This product is intended for adults and should be stored out of reach of children. Children under 12 years of age should only use this product with the guidance of a dentist.

    Avoid contact with eyes: In case of accidental contact with eyes, rinse thoroughly with water. Seek medical attention if irritation continues.

    Example: "For external use only. Do not swallow. Consult a dentist if you have sensitive teeth or gums. Discontinue use if sensitivity occurs. Keep out of reach of children and avoid contact with eyes."

  • INDICATIONS & USAGE

    Indications:

    This product is intended for individuals looking to remove surface stains and achieve a natural whitening effect.
    Suitable for adults experiencing mild tooth discoloration caused by coffee, tea, red wine, or smoking.
    Not recommended for individuals with sensitive teeth or gums. Please consult a dentist before use if you have dental concerns.

    Usage:

    Use twice daily, morning and night. Apply a pea-sized amount of toothpaste to your toothbrush.
    Gently brush teeth for at least two minutes, ensuring the toothpaste covers all tooth surfaces.
    Rinse thoroughly after brushing; avoid swallowing.
    For optimal whitening results, continue use for at least two weeks, and limit consumption of stain-causing foods and drinks.

  • STOP USE

    Stop Use:

    If irritation or discomfort occurs: Discontinue use immediately if you experience persistent irritation, discomfort, or unusual sensitivity in teeth or gums.

    If symptoms worsen: Stop using the product if symptoms such as pain, inflammation, or tooth sensitivity intensify. Consult a dentist before resuming use.

    If allergic reaction develops: Discontinue use if you notice signs of an allergic reaction, such as redness, itching, or swelling in the mouth or on the gums.

  • KEEP OUT OF REACH OF CHILDREN

    Here’s how the KEEP OUT OF REACH OF CHILDREN section could be presented for a whitening toothpaste:

    Keep Out of Reach of Children:

    This product is intended for adult use only. Do not allow children to use without supervision or the guidance of a dentist.

    In case of accidental ingestion by a child, seek immediate medical assistance or contact a Poison Control Center.

    Example: "Keep out of reach of children. For adult use only. If swallowed by a child, get medical help or contact a Poison Control Center immediately."

  • DOSAGE & ADMINISTRATION

    Here’s how the DOSAGE & ADMINISTRATION section for a whitening toothpaste could be structured:

    Dosage & Administration:

    Recommended Dosage: Use a pea-sized amount of toothpaste per brushing session.

    Frequency of Use: Brush teeth twice daily, in the morning and at night, or as directed by a dentist.

    Administration Instructions:

    Apply a pea-sized amount of toothpaste to a toothbrush.
    Brush teeth gently for at least two minutes, covering all tooth surfaces.
    Rinse thoroughly after brushing and avoid swallowing the product.

    Duration for Optimal Results: For best whitening results, use consistently for a minimum of two weeks. Consult a dentist if additional whitening is desired or if you plan to use for an extended period.

    Example: "Apply a pea-sized amount and brush twice daily for two minutes, ensuring full coverage. Rinse thoroughly after use. For optimal whitening, continue use for at least two weeks."

  • INACTIVE INGREDIENT

    LYSOZYME

    SODIUM PHYTATE

    SORBITOL

    WATER

    SACCHARIN SODIUM

    SODIUM LAURYL SULFATE

  • DOSAGE & ADMINISTRATION

    HYDRATED SILICA

    XANTHAN GUM

    GLYCERIN

  • PRINCIPAL DISPLAY PANEL

    NDC WHITENING TOOTHPASTEI 100g 20241101

  • INGREDIENTS AND APPEARANCE
    WHITENING 
    yayashi whitening gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84727-051
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA0.5 g  in 0.5 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 g  in 0.5 g
    XANTHAN GUM (UNII: TTV12P4NEE) (XANTHAN GUM - UNII:TTV12P4NEE) XANTHAN GUM0.5 g  in 0.5 g
    Inactive Ingredients
    Ingredient NameStrength
    LYSOZYME (UNII: 968JKA7T33) 0.5 g  in 0.5 g
    SODIUM PHYTATE (UNII: 88496G1ERL) 0.5 g  in 0.5 g
    SORBITOL (UNII: 506T60A25R) 0.5 g  in 0.5 g
    WATER (UNII: 059QF0KO0R) 0.5 g  in 0.5 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.5 g  in 0.5 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.5 g  in 0.5 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84727-051-01100 g in 1 TUBE; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/01/2024
    Labeler - Guangzhou Baishili Trading Co., Ltd (709042161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Baishili Trading Co., Ltd709042161manufacture(84727-051)