WHITENING- yayashi whitening gel, dentifrice

Whitening by

Drug Labeling and Warnings

Whitening by is a Otc medication manufactured, distributed, or labeled by Guangzhou Baishili Trading Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

WHITENING 
yayashi whitening gel, dentifrice

Product 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)