Oral Pro Care by Den-Mat Holdings, LLC

Oral Pro Care by

Drug Labeling and Warnings

Oral Pro Care by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAL PRO CARE- cavity protection gel gel 
Den-Mat Holdings, LLC

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Active Ingredient

Stannous Flouride 0.4% (0.12% w/v flouride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warnings

This is an anticavity flouride prevent treatment gel, not a toothpaste. Read directions carefully before using.

Using this product may produce surface staining of the teeth. Adequate tooth brushing may prevent stains which are not harmful or permanent and may be removed by a dentist.

Keep out of reach of children section

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

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 doctor.
• Children under 2 years of age: Consult a
  dentist or doctor.
• Do not swallow.
• To minimize swallowing, use a pea-sized
  amount in children under 6.
• Instruct children under 6 years of age in
  good brushing and rinsing habits.
• Supervise children as necessary until
  capable of using without supervision.

Other Information

For your protection, do not use if the tip under the cap is cut or tampered.

Inactive Ingredients

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or Comments?

800-433-6628

Principal Display Panel

OralProCare™

Clinical Strength

Cavity Protection Gel

Formulated with Stannous Flouride

Fresh Mint Flavor

Net Wt 4 oz.(113.4 g)

Labeling

ORAL PRO CARE 
cavity protection gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.969 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TROLAMINE (UNII: 9O3K93S3TK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-600-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	06/14/2023	11/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/14/2023	11/30/2023

Labeler - Den-Mat Holdings, LLC (809857704)

Registrant - Den-Mat Holdings, LLC (809857704)

Revised: 7/2024

Document Id: 1e69868b-6063-1f61-e063-6394a90aa2a6

34390-5

Set id: fd187009-9be8-5326-e053-6294a90a538b

Version: 3

Effective Time: 20240729