SPL v1
SPL
SPL Set ID 263b2132-78f3-ac81-e063-6394a90a9d37
Route
DENTAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dipropylene Glycol (1 mg)
Inactive Ingredients
Menthol Pvp Sodium Chlorite Water Sodium Bicarbonate Edta Cellulose Gum Glycerin Carbomer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-06
Description

Propylene Glycol

Purpose

Tooth Brighting

Medication Information

Purpose

Tooth Brighting

Description

Propylene Glycol

Dosage

Once a day in the morning and evening

Section 51945-4

Warning

For cosmetic use only.

Do not swallow. Avoid contact with eyes.

Store in a cool area away from heat.

Keep out of reach of children.

Not Use

Not suitable for use by children, pregnantor breast feeding people.

Stop Use

This product may cause allergic reactions in asmall number of people.

lf youexperience any discomfort,please stop using it immediately.

How to Use

Step 1:Brush your teeth.

Step 2:Twist the base of the pen until you see gel.

Step 3:Apply the gel in a brushing motion.

Step 4:Rinse mouth after 1 minute.

Out of Children

KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Purpose Section

Tooth Brighting

Active Ingredient

Propylene Glycol

Inactive Ingredient

Aqua, Glycerin,Carbomer, Cellulose Gum, EDTA,Menthol, PVP, Sodium Bicarbonate,Sodium Chlorite.

Structured Label Content

Dosage

Once a day in the morning and evening

Section 51945-4 (51945-4)

Warning

For cosmetic use only.

Do not swallow. Avoid contact with eyes.

Store in a cool area away from heat.

Keep out of reach of children.

Not Use (not use)

Not suitable for use by children, pregnantor breast feeding people.

Stop Use (stop use)

This product may cause allergic reactions in asmall number of people.

lf youexperience any discomfort,please stop using it immediately.

How to Use (HOW TO USE)

Step 1:Brush your teeth.

Step 2:Twist the base of the pen until you see gel.

Step 3:Apply the gel in a brushing motion.

Step 4:Rinse mouth after 1 minute.

Out of Children (OUT OF CHILDREN)

KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Purpose Section (Purpose section)

Tooth Brighting

Active Ingredient (Active ingredient)

Propylene Glycol

Inactive Ingredient (Inactive ingredient)

Aqua, Glycerin,Carbomer, Cellulose Gum, EDTA,Menthol, PVP, Sodium Bicarbonate,Sodium Chlorite.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:16.915770 · Updated: 2026-03-14T23:04:52.865909