SPL v2
SPL
SPL Set ID 42f98b14-d1d5-4af8-e063-6294a90a8f67
Route
TOPICAL
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mentha Piperita (peppermint) Leaf (0.25 mg) Lonicera Caprifolium Whole (0.01 mg)
Inactive Ingredients
1,2-hexanediol Sodium Lauroyl Sarcosinate Sorbitol Glycerin Magnesium Stearate Sodium Bicarbonate Wheat Sprout

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-07

Description

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT、LONICERA CAPRIFOLIUM (HONEYSUCKLE) EXTRACT


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Indications and Usage

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Dosage and Administration

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Description

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT、LONICERA CAPRIFOLIUM (HONEYSUCKLE) EXTRACT

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

SODIUM BICARBONATE、GLYCERIN、PPG-10 SORBITOL、TRITICUM VULGARE (WHEAT) STARCH、MAGNESIUM STEARATE、1,2-HEXANEDIOL、SODIUM LAUROYL SARCOSINATE

Section 51945-4

Section 55105-1

Bright and clean

Mouthguard

Lasting

Section 55106-9

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT、LONICERA CAPRIFOLIUM (HONEYSUCKLE) EXTRACT


Structured Label Content

Indications and Usage (34067-9)

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Dosage and Administration (34068-7)

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

1. Pour an appropriate amount of teeth whitening powder (1/2 to 3/4 teaspoons) into a cup of warm water. Do not use too much whitening powder, as it may irritate your teeth and gums.

2. Mix the whitening powder and water evenly with a stirring rod or toothbrush until there are no lumps.

3. Dip your mouth into a cup containing a whitening mixture and keep it for about 30 minutes. You can gently brush your teeth with a toothbrush to help remove any residue.

4. After completion, rinse your mouth with clean water and spit it out. Do not brush your teeth immediately as they may still be slightly sensitive.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

SODIUM BICARBONATE、GLYCERIN、PPG-10 SORBITOL、TRITICUM VULGARE (WHEAT) STARCH、MAGNESIUM STEARATE、1,2-HEXANEDIOL、SODIUM LAUROYL SARCOSINATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Bright and clean

Mouthguard

Lasting

Section 55106-9 (55106-9)

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT、LONICERA CAPRIFOLIUM (HONEYSUCKLE) EXTRACT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)