STANGARD- topical snf fluoride gel gel

Stangard by

Drug Labeling and Warnings

Stangard by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Active Ingredient: Stannous Fluoride 0.4%

Purpose: Anticavity

Warnings:

This is an anticavity preventive treatmeng gel, not a toothpaste.

Read directions carefully before using

Keep out of reach of children

If more than amount used for brushing is swallowed, seek professional assistance or contact a Poison Control Center immediately.

Do not use if foil seal is missing or damaged.

Directions

Adults and children 6 years of age and older:

Before dispensing, remove cap and peel off seal

Use once daily after brushing with toothpaste

Apply a small amount of gel totoothbrush and brush teeth thoroughly

Allow the gel to remain on teeth for one minute

Spit out the gel. Do not swallow.

Do not eat, drink or rinse for 30 minutes after brushing

Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without adult supervision.

Children under age 6: Consult a dentist or physician.

Inactive Ingredients

Glycerin, carbomer 940, natural and artificial flavors

Other Information:

Store at 15-30°C (59-86ºF)

Keep tightly closed when not in use

Expiration Date can be found on tube crimp

StanGard

StanGard Preventive Treatment Gel Mint Flavor 11-650

INGREDIENTS AND APPEARANCE

STANGARD 
topical snf fluoride gel gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0271
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	3.8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	12.56 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0271-1	122 g in 1 TUBE; Type 0: Not a Combination Product	04/01/1981

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		04/01/1981

Labeler - Pascal Company, Inc. (009260217)

Registrant - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc.		009260217	manufacture(10866-0271)