Label: BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE- botao kids strawberry flavored toothpaste with fluoride paste
- NDC Code(s): 69435-1405-1
- Packager: Peer Pharm Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 9, 2023
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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 -
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 child’s brushing and rinsing to minimize swallowing
• Children under 2 years : Ask a dentist or physician -
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 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
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INGREDIENTS AND APPEARANCE
BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE
botao kids strawberry flavored toothpaste with fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1405 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.122 g in 100 mL Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) STRAWBERRY (UNII: 4J2TY8Y81V) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CHAMOMILE (UNII: FGL3685T2X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1405-1 1 in 1 CARTON 12/19/2022 1 75 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/19/2022 Labeler - Peer Pharm Ltd. (514678390) Registrant - Peer Pharm Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd. 514678390 manufacture(69435-1405)
