BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE- botao kids strawberry flavored toothpaste with fluoride paste

Botao Kids Strawberry Flavored with Fluoride by

Drug Labeling and Warnings

Botao Kids Strawberry Flavored with Fluoride by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

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

Questions or comments

Call 951-297-7976 or visit 

www.botaobaby.com

Product label

INGREDIENTS AND APPEARANCE

BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE 
botao kids strawberry flavored toothpaste with fluoride paste

Product 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)