SPL v12
SPL
SPL Set ID cbf7907e-72c7-4328-8bd4-bf70daa35ef9
Route
ORAL
Published
Effective Date 2011-10-25
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.12 g)
Inactive Ingredients
Glycerin Hydroxyethyl Cellulose (2000 Cps At 1%) Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 1989-01-01

Description

Active Ingredient: Stannous Fluoride


Medication Information

Description

Active Ingredient: Stannous Fluoride

Use

Aids in the prevention of dental decay.

Warnings

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

Package Label

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel



Manufactured by Massco Dental











Active Ingredient

Active Ingredient: Stannous Fluoride

Other Information

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

Directions for Use

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.



Children 6-11 Years:  See directions above.  Adult supervision required.



Children Under 6: Consult a Dentist or Physician.

Inactive Ingredients

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

Questions ? Comments ?

Questions?? Comments??



Call 1-479-787-5168 M-F 9am to 5pm CST

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Use (USE)

Aids in the prevention of dental decay.

Warnings (WARNINGS)

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

Package Label (PACKAGE LABEL)

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel



Manufactured by Massco Dental











Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Stannous Fluoride

Other Information (OTHER INFORMATION)

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

Directions for Use (DIRECTIONS FOR USE)

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.



Children 6-11 Years:  See directions above.  Adult supervision required.



Children Under 6: Consult a Dentist or Physician.

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

Questions ? Comments ? (QUESTIONS ? COMMENTS ?)

Questions?? Comments??



Call 1-479-787-5168 M-F 9am to 5pm CST

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)