Botao Kids Strawberry Flavored With Fluoride Paste
FDA Label NDC 69435-1405
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Botao Kids Strawberry Flavored With Fluoride (NDC 69435-1405). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sodium Fluoride 0.225%
(0.122% w/v fluoride ion)
Purpose
Anticavity
Uses
Helps to maintain and protect teeth and gums from the very first tooth
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 |
• 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 child’s brushing and rinsing to minimize swallowing
• Children under 2 years : Ask a dentist or physician
• 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 child’s brushing and rinsing to minimize swallowing
• Children under 2 years : Ask a dentist or physician
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
Product Label
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