Optimax Purple Anticavity Fluoride Toothpaste

Optimax Purple Anticavity Fluoride Toothpaste
SPL v1
SPL
SPL Set ID 8264e849-a6b3-4953-a85b-da9d4e7f5a70
Route
DENTAL
Published
Effective Date 2025-08-29
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 Menthol, Unspecified Form Hydroxyethyl Cellulose, Unspecified Sodium Silicate Saccharin Sodium D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31

Description

Sodium monofluorophosphate 0.76% (0.1% W/W fluoride ion).

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Sodium monofluorophosphate 0.76% (0.1% W/W 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 monofluorophosphate 0.76% (0.1% W/W fluoride ion).

Other Information
  • Store in a cool place, below 86° F, 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, Aroma, Cellulose Gum, Mentholum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No.33, FD&C Blue No.1.

Questions Or Comments

For customer enquiries, please contact: [email protected] 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 monofluorophosphate 0.76% (0.1% W/W fluoride ion).

Other Information (Other information)
  • Store in a cool place, below 86° F, 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, Aroma, Cellulose Gum, Mentholum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No.33, FD&C Blue No.1.

Questions Or Comments (Questions or comments)

For customer enquiries, please contact: [email protected] 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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