84844-006

84844-006
SPL v1
SPL
SPL Set ID 25be6c8d-aa0e-32dc-e063-6294a90a413e
Route
TOPICAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 g)
Inactive Ingredients
Carbomer Carboxymethylcellulose Calcium Glycerin Propylene Glycol Polyvinyl Alcohol (94000 Mw) Sodium Hydroxide Water Sodium Phytate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

Menthol 0.5%

Purpose

Relieve tooth pain


Medication Information

Purpose

Relieve tooth pain

Description

Menthol 0.5%

Use

•Keep hands dry and take off the strips

•Gently press it onto the teeth

•Leave the patch on for 30 minutes,Do not eat or drink during the process

•Remove and discard the patch,Then rinse off the excess gel.

Stop Use

If you experience any discomfort, stop using and consult a dentist immediately

Warnings

Avoid contact with eyes and skin

Ask Doctor

If you experience any discomfort, stop using and consult a dentist immediately

Directions

•Keep hands dry and take off the strips

•Gently press it onto the teeth

•Leave the patch on for 30 minutes,Do not eat or drink during the process

•Remove and discard the patch,Then rinse off the excess gel.Please store in a dry and cool place away from direct sunlight ,keep out of reach of young children.

Do Not Use

Should not be used if you have mouth sores/exposed gums or after oral surgery

When Using

Disposable products Please do not reuse,Not for use by children under 16 years old

Active Ingredient

Menthol 0.5%

Other Information

To achieve and maintain better results,Minimize or avoid smoking、Drink coffee、Tea、Coke or red wine,And edible cherries,blueberry,Highly pigmented foods

Inactive Ingredients

Glycerol,Propylene Glycol,Water,Sodium Phytate,Carbomer,Carboxymethyl,Polyvinylpyrrolidone,Sodium Hydroxide

Principal Display Panel

Keep Oot of Reach of Children

Not for use by children under 16 years old,keep out of reach of children.


Structured Label Content

Use

•Keep hands dry and take off the strips

•Gently press it onto the teeth

•Leave the patch on for 30 minutes,Do not eat or drink during the process

•Remove and discard the patch,Then rinse off the excess gel.

Purpose

Relieve tooth pain

Stop Use

If you experience any discomfort, stop using and consult a dentist immediately

Warnings

Avoid contact with eyes and skin

Ask Doctor

If you experience any discomfort, stop using and consult a dentist immediately

Directions

•Keep hands dry and take off the strips

•Gently press it onto the teeth

•Leave the patch on for 30 minutes,Do not eat or drink during the process

•Remove and discard the patch,Then rinse off the excess gel.Please store in a dry and cool place away from direct sunlight ,keep out of reach of young children.

Do Not Use (Do not use)

Should not be used if you have mouth sores/exposed gums or after oral surgery

When Using

Disposable products Please do not reuse,Not for use by children under 16 years old

Active Ingredient

Menthol 0.5%

Other Information (Other information)

To achieve and maintain better results,Minimize or avoid smoking、Drink coffee、Tea、Coke or red wine,And edible cherries,blueberry,Highly pigmented foods

Inactive Ingredients (Inactive ingredients)

Glycerol,Propylene Glycol,Water,Sodium Phytate,Carbomer,Carboxymethyl,Polyvinylpyrrolidone,Sodium Hydroxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Not for use by children under 16 years old,keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)