HONEST-PASTE KIDS- dental type silica paste 
BOONCO Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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80925-201

Active ingredients

Dental type silica 8%

Purpose

Anticavity

Use

helps protect against cavities

Warnings

When using this product, avoid contact with eyes and lips. If contact occurs, rinse with water.

Stop use and ask a dentist if

irritation or redness develops.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

glycerin, cellulose gum, ascorbic acid, rosemary extract, scutellaria root extract, green tea extract, xylitol, calendula extract, chamomile extract, enzyme treatment stevia, l-menthol, raspberry flavor, sorbitol, purified water

Package Label

60g NDC: 80925-201-01 Label

HONEST-PASTE KIDS 
dental type silica paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80925-201
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ROSEMARY (UNII: IJ67X351P9)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
XYLITOL (UNII: VCQ006KQ1E)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80925-201-0160 g in 1 TUBE; Type 0: Not a Combination Product10/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/28/2020
Labeler - BOONCO Co., Ltd (694871408)
Registrant - BOONCO Co., Ltd (694871408)
Establishment
NameAddressID/FEIBusiness Operations
BOONCO Co., Ltd694871408manufacture(80925-201)

Revised: 1/2022
Document Id: d508bfb0-064a-3c7a-e053-2995a90a5bdb
Set id: b2b435ec-8036-ca87-e053-2a95a90aebf4
Version: 2
Effective Time: 20220107
 
BOONCO Co., Ltd