DR.PAUHLS TOOTHPAST E VANILLE BLACK TEA FLAVOR- silicon dioxide, pyridoxine hydrochloride paste, dentifrice 
CURESCRIPT

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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ACTIVE INGREDIENT

Active ingredients: SILICA 13.0%, PYRIDOXINE HYDROCHLORIDE 0.05%

INACTIVE INGREDIENT

Inactive ingredients:

SORBITOL, SODIUM PCA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, MENTHOL, XYLITOL, CITRUSGRANDIS (GRAPEFRUIT) SEED EXTRACT, SODIUM SACCHARIN HYDROXYAPATITE, CAMELLIA SINENSIS LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, PROPOLIS EXTRACT

PURPOSE

Purpose: Anti-plaque, Anti-caries, Anti-periodontitis

WARNINGS

Warnings:

Keep out of the reach of children under 6 years of age.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

Uses:

- Helps protect against cavities

- reduce plaque

- gum health

- Helps protect against gingivitis, periodontitis

- Helps freshen breath

- brightening teeth

Directions

Directions:

Adults and children 2 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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DR.PAUHLS TOOTHPAST E VANILLE BLACK TEA FLAVOR 
silicon dioxide, pyridoxine hydrochloride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72265-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE13.0 g  in 100 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72265-030-021 in 1 CARTON07/01/2018
1NDC:72265-030-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2018
Labeler - CURESCRIPT (694894509)
Registrant - CURESCRIPT (694894509)
Establishment
NameAddressID/FEIBusiness Operations
Kumho Dental Pharm. Co., Ltd.631133766manufacture(72265-030)

Revised: 7/2018
Document Id: 8e1504ee-9706-4395-a066-23c59d84c6ca
Set id: eee91eb6-a9d2-481c-822c-8109684da87d
Version: 1
Effective Time: 20180726
 
CURESCRIPT