Optimax Anticavity Fluoride Toothpaste, Watermelon

Optimax Anticavity Fluoride Toothpaste, Watermelon
SPL v1
SPL
SPL Set ID b506df13-649f-4615-bc25-6ae08bd56b18
Route
DENTAL
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Water Glycerin Sorbitol Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Hydroxyethylcellulose Sodium Silicate Sodium Saccharin Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-04

Description

Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).

Use

helps protect against cavities

Warnings

Directions
 Adults and children

2 years of age & older: 
 Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children under 6 years of age:  Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

 Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).

Other Information
  • Store in a cool place, below 86ºF, away from heat
  • Do not use if quality seal is broken or missing
Package Labeling:

Inactive Ingredients

Calcium Carbonate, Aqua, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, FD&C Yellow No. 5, FD&C Blue No. 1.

Questions Or Comments

For customer enquiries, please contact: [email protected]

White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell, California, 95008. www.optimax.today

Keep Out of Reach of Children Under 6 Years of Age.

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


Structured Label Content

Use

helps protect against cavities

Purpose

Anticavity toothpaste

Warnings

Directions
 Adults and children

2 years of age & older: 
 Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children under 6 years of age:  Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

 Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient (Active ingredient)

Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).

Other Information (Other information)
  • Store in a cool place, below 86ºF, away from heat
  • Do not use if quality seal is broken or missing
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Calcium Carbonate, Aqua, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, FD&C Yellow No. 5, FD&C Blue No. 1.

Questions Or Comments (Questions or comments)

For customer enquiries, please contact: [email protected]

White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell, California, 95008. www.optimax.today

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

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


Advanced Ingredient Data


Raw Label Data

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