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NDC 69301-0034-15 Top Quality Mfg APF 5.6 g/454g Details

Top Quality Mfg APF 5.6 g/454g

Top Quality Mfg APF is a DENTAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Top Quality Manufacturing, Inc.. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 69301-0034-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	69301-0034
Product ID	69301-034_d60637c5-dee7-8455-e053-2995a90a3c29
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	Top Quality Mfg APF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	5.6
Active Ingredient Units	g/454g
Substance Name	SODIUM FLUORIDE
Labeler Name	Top Quality Manufacturing, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69301-0034-15 (69301003415)

Pricing Information	N/A
NDC Package Code	69301-034-15
Billing NDC	69301003415
Package	454 g in 1 BOTTLE, PLASTIC (69301-034-15)
Marketing Start Date	2014-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cc819868-9633-4b5f-800f-698f936e6a75 Details

Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Fluoride Treatment Gel

Indications and Usage:

A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings:

Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
Read directions carefully before using.

Dosage and Administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

Store at controlled room temperature 59° to 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients:

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOP QUALITY MFG APF

sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:69301-034
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5.6 g in 454 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE, VANILLA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69301-034-15	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/01/2014

Labeler - Top Quality Manufacturing, Inc. (113630649)

Revised: 1/2022

Document Id: d60637c5-dee7-8455-e053-2995a90a3c29

Set id: cc819868-9633-4b5f-800f-698f936e6a75

Version: 3

Effective Time: 20220120