SPL v2
SPL
SPL Set ID 425cec0e-aa74-5341-e063-6294a90ac86b
Route
TOPICAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mentha Piperita (peppermint) Leaf (0.6 mg)
Inactive Ingredients
Xylitol Sodium Saccharin Sodium Lauryl Sulfate Aqua Glycerin Croscarmellose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-30

Description

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT

Purpose

Which can effectively clean the mouth, maintain oral hygiene, effectively freshen the breath after use, and keep the mouth moist, fresh and lasting


Medication Information

Indications and Usage

1. Take an appropriate amount of toothpaste on the toothbrush

2. Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

Purpose

Which can effectively clean the mouth, maintain oral hygiene, effectively freshen the breath after use, and keep the mouth moist, fresh and lasting

Dosage and Administration

1. Take an appropriate amount of toothpaste on the toothbrush

2. Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

Description

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT

Use

1.Take an appropriate amount of toothpaste on the toothbrush

2.Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

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 51727-6

AQUA、GLYCERIN、SODIUM LAURYL SULFATE、CROSCARMELLOSE、SODIUM SACCHARIN、XYLITOL

Section 51945-4

Warnings

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.

Do Not Use

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT


Structured Label Content

Use

1.Take an appropriate amount of toothpaste on the toothbrush

2.Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

Indications and Usage (34067-9)

1. Take an appropriate amount of toothpaste on the toothbrush

2. Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

Dosage and Administration (34068-7)

1. Take an appropriate amount of toothpaste on the toothbrush

2. Gently brush your teeth in circular motions from inside to outside for 1-2 minutes

3.Rinse with clean water.

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 51727-6 (51727-6)

AQUA、GLYCERIN、SODIUM LAURYL SULFATE、CROSCARMELLOSE、SODIUM SACCHARIN、XYLITOL

Section 51945-4 (51945-4)

Purpose

Which can effectively clean the mouth, maintain oral hygiene, effectively freshen the breath after use, and keep the mouth moist, fresh and lasting

Warnings

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.

Do Not Use (Do not use)

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)