SPL v2
SPL
SPL Set ID bb775b83-ace6-455d-e053-2995a90a828e
Route
DENTAL
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Stevia Leaf Sodium Methyl Cocoyl Taurate Pyridoxine Benzoic Acid Theanine Water Hydrated Silica Sodium Bicarbonate Carboxymethylcellulose Sodium Titanium Dioxide Xylitol Sorbitol Glycerin Caffeine Methylcobalamin Ginger Nutmeg Melissa Officinalis Leaf Chamomile Melatonin Cinnamon Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-08-16

Description

Sodium fluoride 0.24%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.24%

Uses

aids in the prevention of dental cavities.

Section 50565-1

Keep out of the reach of children under 6 years of age.

Section 51945-4

Warnings

If more than used for brushing is accidentally swallowed, get medical help or

contact a Poison Control Center right away.

Attention

Twist off cap to remove foil seal

Do not use if the safety seal is missing or broken

This product contains caffeine, which could be something to avoid if you are sensitive

For human use only

Directions

1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste

2 Brush thoroughly for 2 minutes.

3 Rinse and spit out paste after brushing.

4 Do not swallow.

Active Ingredients

Sodium fluoride 0.24%

Inactive Ingredients

Inactive ingredients (up): Sorbitol, glycerin, xylitol, water, hydrated silica, chamomile, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, sodium bicarbonate, lemon balm, titanium dioxide, stevia, sodium fluoride, benzoic acid, melatonin, L-Theanine

Inactive ingredients (down): sorbitol, glycerin, xylitol, hydrated silica, water, anthemis nobilis (chamomile), sodium bicarbonate, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, lemon balm extract, titanium dioxide, stevia, benzoic acid, melatonin, l-theanine, nutmeg, ginger root, cinnamomum zeylanicum (cinnamon) oil

Need Help With Anything?

We want to help!

Talk to a human: +1 714 363 3599

Write to us: [email protected]

Distributed by TAO Clean® LLC. Orange, CA 92866

Proudly made in the USA

UP TOOTHPASTE, LEMON CITRON, 60 ML 81301-0512-01 • DOWN TOOTHPASTE, GINGERSNAP, 60 ML 81301-0513-01

20352 • BA-0511-IM


Structured Label Content

Uses

aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Keep out of the reach of children under 6 years of age.

Section 51945-4 (51945-4)

Purpose

Anticavity

Warnings

If more than used for brushing is accidentally swallowed, get medical help or

contact a Poison Control Center right away.

Attention

Twist off cap to remove foil seal

Do not use if the safety seal is missing or broken

This product contains caffeine, which could be something to avoid if you are sensitive

For human use only

Directions

1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste

2 Brush thoroughly for 2 minutes.

3 Rinse and spit out paste after brushing.

4 Do not swallow.

Active Ingredients (Active ingredients)

Sodium fluoride 0.24%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients (up): Sorbitol, glycerin, xylitol, water, hydrated silica, chamomile, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, sodium bicarbonate, lemon balm, titanium dioxide, stevia, sodium fluoride, benzoic acid, melatonin, L-Theanine

Inactive ingredients (down): sorbitol, glycerin, xylitol, hydrated silica, water, anthemis nobilis (chamomile), sodium bicarbonate, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, lemon balm extract, titanium dioxide, stevia, benzoic acid, melatonin, l-theanine, nutmeg, ginger root, cinnamomum zeylanicum (cinnamon) oil

Need Help With Anything? (Need help with anything?)

We want to help!

Talk to a human: +1 714 363 3599

Write to us: [email protected]

Distributed by TAO Clean® LLC. Orange, CA 92866

Proudly made in the USA

UP TOOTHPASTE, LEMON CITRON, 60 ML 81301-0512-01 • DOWN TOOTHPASTE, GINGERSNAP, 60 ML 81301-0513-01

20352 • BA-0511-IM


Advanced Ingredient Data


Raw Label Data

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