83778-009 001update

83778-009 001update
SPL v1
SPL
SPL Set ID 2b2a0b47-7628-4b85-e063-6294a90a45a0
Route
TOPICAL
Published
Effective Date 2023-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrophosphoric Acid (0.5 g)
Inactive Ingredients
Sorbitol Fd&c Blue No. 1 Ethylhexylglycerin D&c Red No. 33 Carboxymethylcellulose Sodium, Unspecified Form Glycerin Water Hydrated Silica Peppermint Oil Sucralose Phenoxyethanol Xylitol Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-30

Description

Tetrasodium Pyrophosphate

Purpose

Teeth cleaning


Medication Information

Purpose

Teeth cleaning

Description

Tetrasodium Pyrophosphate

Use

Those who want to clean and whiten their teeth.

Stop Use

If there is any discomfort, please stop using.

Warnings

Product is not intended for use by children. Do not swallow. Do not use in eye area.

Ask Doctor

If there is any discomfort, please consult a dentist immediately

Directions

1. Apply 2 pumps to a soft bristle toothbrush.

2. Gently brush it a circular motion for 2 minutes.

3. Expel excess and rinse mouth after use, do not swallow.

Do Not Use

Product is not intended for use by children.

When Using

Do not swallow. Do not use in eye area.

Active Ingredient

Tetrasodium Pyrophosphate

Other Information

please keep in dry and cool place

Inactive Ingredients

Glycerin、Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Polysorbate 80、Cellulose Gum、Mentha Piperita(peppermint) oil 、Phenoxyethanol、Sucralose、Ethylhexylglycerin、CI17200/D&C Red No.33、CI 42090/FD&C Blue No.1

Principal Display Panel

Keep Oot of Reach of Children

keep out of reach of young children


Structured Label Content

Use

Those who want to clean and whiten their teeth.

Purpose

Teeth cleaning

Stop Use

If there is any discomfort, please stop using.

Warnings

Product is not intended for use by children. Do not swallow. Do not use in eye area.

Ask Doctor

If there is any discomfort, please consult a dentist immediately

Directions

1. Apply 2 pumps to a soft bristle toothbrush.

2. Gently brush it a circular motion for 2 minutes.

3. Expel excess and rinse mouth after use, do not swallow.

Do Not Use (Do not use)

Product is not intended for use by children.

When Using

Do not swallow. Do not use in eye area.

Active Ingredient

Tetrasodium Pyrophosphate

Other Information (Other information)

please keep in dry and cool place

Inactive Ingredients (Inactive ingredients)

Glycerin、Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Polysorbate 80、Cellulose Gum、Mentha Piperita(peppermint) oil 、Phenoxyethanol、Sucralose、Ethylhexylglycerin、CI17200/D&C Red No.33、CI 42090/FD&C Blue No.1

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

keep out of reach of young children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)