BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE- botao kids strawberry flavored toothpaste with fluoride paste 
Peer Pharm Ltd.

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.

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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

image description

BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE 
botao kids strawberry flavored toothpaste with fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1405
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.122 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1405-11 in 1 CARTON12/19/2022
175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/19/2022
Labeler - Peer Pharm Ltd. (514678390)
Registrant - Peer Pharm Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharm Ltd.514678390manufacture(69435-1405)

Revised: 3/2023
Document Id: f6791073-a681-67ed-e053-2a95a90a4dff
Set id: 48b8d884-5e15-4145-8521-ae9ee482e392
Version: 1
Effective Time: 20230309
 
Peer Pharm Ltd.