Label: WHITENING- yayashi whitening gel, dentifrice
- NDC Code(s): 84727-051-01
- Packager: Guangzhou Baishili Trading Co., Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 12, 2024
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- PURPOSE
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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."
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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.
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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."
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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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITENING
yayashi whitening gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84727-051 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA 0.5 g in 0.5 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.5 g in 0.5 g XANTHAN GUM (UNII: TTV12P4NEE) (XANTHAN GUM - UNII:TTV12P4NEE) XANTHAN GUM 0.5 g in 0.5 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:84727-051-01 100 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 11/01/2024 Labeler - Guangzhou Baishili Trading Co., Ltd (709042161) Establishment Name Address ID/FEI Business Operations Guangzhou Baishili Trading Co., Ltd 709042161 manufacture(84727-051)