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NDC 72265-0100-02 DR.PAUHLS NATURAL TONE UP TOOTH .17; 1.81; 5.95 g/85g; g/85g; g/85g Details

DR.PAUHLS NATURAL TONE UP TOOTH .17; 1.81; 5.95 g/85g; g/85g; g/85g

DR.PAUHLS NATURAL TONE UP TOOTH is a TOPICAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by CURESCRIPT. The primary component is .ALPHA.-TOCOPHEROL ACETATE; HYDROGEN PEROXIDE; SILICON DIOXIDE.

Product Information

NDC	72265-0100
Product ID	72265-100_387db461-f3c7-42d6-92f3-5b16468e98f5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DR.PAUHLS NATURAL TONE UP TOOTH
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrogen Peroxide Solution, Colloidal silicon dioxide, Tocopherol Acetate
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	TOPICAL
Active Ingredient Strength	.17; 1.81; 5.95
Active Ingredient Units	g/85g; g/85g; g/85g
Substance Name	.ALPHA.-TOCOPHEROL ACETATE; HYDROGEN PEROXIDE; SILICON DIOXIDE
Labeler Name	CURESCRIPT
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72265-0100-02 (72265010002)

Pricing Information	N/A
NDC Package Code	72265-100-02
Billing NDC	72265010002
Package	1 TUBE in 1 CARTON (72265-100-02) / 85 g in 1 TUBE (72265-100-01)
Marketing Start Date	2021-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3614aea9-9897-41de-8744-ef640df7c062 Details

ACTIVE INGREDIENTS

Hydrogen Peroxide Solution (35%) 2.14 %

Colloidal silicon dioxide 7.0%

Tocopherol Acetate 0.2%

INACTIVE INGREDIENTS

D-Sorbitol Solution, Deionized Water , Glycerin ,Carboxymethylcellulose Sodium ,Sodium Cocoyl Glutamate ,Sodium Lauroyl Sarcosinate ,Grapefruit Seed Extract ,Enzymatically Modified Stevia ,Xylitol ,Xanthan Gum ,Melon champagne Flavor ,Citric Acid ,L-Menthol ,Mentha Oil ,Spearmint oil ,Polysorbate 60,Hydroxyapatite ,Eucalyptus Oil,Parsley Extract ,Salicylic Acid,Clove Oil

PURPOSE

Whitening

Anti plaque

prevent gingivitis

WARNINGS

■ Do not use for any other purposes except brushing your teeth.

■ Do not swallow, and rinse your mouth adequately after use.

■ Consult your physician or dentist and follow their directions if you swallow a large amount of toothpaste.

■ Discontinue use and consult your physician or dentist if gum or mouth pain occurs after using this toothpaste

■ Keep out of reach of children and guide them if they use this toothpaste.

■ Store it away from high or low temperature and from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

■ Keep out of reach of children and guide them if they use this toothpaste.

Uses

■ Promotes dental health and removal bad breath, makes tooth bright

Directions

■ Brush the teeth with a suitable amount.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.PAUHLS NATURAL TONE UP TOOTH

hydrogen peroxide solution, colloidal silicon dioxide, tocopherol acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72265-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.81 g in 85 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5.95 g in 85 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.17 g in 85 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72265-100-02	1 in 1 CARTON	02/01/2021
1	NDC:72265-100-01	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/01/2021

Labeler - CURESCRIPT (694894509)

Registrant - CURESCRIPT (694894509)

Name	Address	ID/FEI	Business Operations
Establishment
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(72265-100)

Revised: 2/2021

Document Id: 387db461-f3c7-42d6-92f3-5b16468e98f5

Set id: 3614aea9-9897-41de-8744-ef640df7c062

Version: 1

Effective Time: 20210209