Botao Kids Strawberry Flavored Toothpaste With Fluoride

Botao Kids Strawberry Flavored Toothpaste With Fluoride
SPL v3
SPL
SPL Set ID 48b8d884-5e15-4145-8521-ae9ee482e392
Route
DENTAL
Published
Effective Date 2023-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.122 g)
Inactive Ingredients
Xylitol Water Glycerin Silicon Dioxide Sodium Benzoate Potassium Sorbate Xanthan Gum Strawberry Anhydrous Citric Acid Chamomile Calendula Officinalis Flower Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-19

Description

Sodium Fluoride 0.225% (0.122% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.225% (0.122% w/v fluoride ion)

Uses

 Helps to maintain and protect teeth and gums from the very first tooth

Section 50565-1

Warnings

Keep out of reach of children under 6 yeras of age.

If more than amount used for brushing is swallowed, get medical help or contact a Poison Control Center right away. Do not use if the seal is broken. 

Directions
 Adults and children 6 years of age and Older

 Brush teeth thoroughly preferably after each meal or at least twice a day or as directed

 by a dentist or a physician

 Children 2 to 6 years  Use only a pea sized amount and supervise childs brushing and rinsing to minimize swallowing
 Children under 2 years  Ask a dentist or physician

Drug Facts

Product Label

Active Ingredients

Sodium Fluoride 0.225%

(0.122% w/v fluoride ion)

Inactive Ingredients

Aqua, Glyceryl Stearate SE, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Ricinus Communis (Castor) Seed Oil, Glycerin, Microcrystalline Cellulose, Caprylhydroxamic Acid, Xanthan Gum, Caprylyl Glycol, Bisabolol, Propanediol, Sodium Phytate, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Aloe Barbadensis Leaf Juice

Questions Or Comments

Call 951-297-7976 or visit 

www.botaobaby.com


Structured Label Content

Uses

 Helps to maintain and protect teeth and gums from the very first tooth

Section 50565-1 (50565-1)

Purpose

Anticavity

Warnings

Keep out of reach of children under 6 yeras of age.

If more than amount used for brushing is swallowed, get medical help or contact a Poison Control Center right away. Do not use if the seal is broken. 

Directions
 Adults and children 6 years of age and Older

 Brush teeth thoroughly preferably after each meal or at least twice a day or as directed

 by a dentist or a physician

 Children 2 to 6 years  Use only a pea sized amount and supervise childs brushing and rinsing to minimize swallowing
 Children under 2 years  Ask a dentist or physician

Drug Facts

Product Label (Product label)

Active Ingredients

Sodium Fluoride 0.225%

(0.122% w/v fluoride ion)

Inactive Ingredients

Aqua, Glyceryl Stearate SE, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Ricinus Communis (Castor) Seed Oil, Glycerin, Microcrystalline Cellulose, Caprylhydroxamic Acid, Xanthan Gum, Caprylyl Glycol, Bisabolol, Propanediol, Sodium Phytate, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Aloe Barbadensis Leaf Juice

Questions Or Comments (Questions or comments)

Call 951-297-7976 or visit 

www.botaobaby.com


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)