Optimax Anticavity Fluoride Watermelon
Optimax Anticavity Fluoride Toothpaste, Watermelon
b506df13-649f-4615-bc25-6ae08bd56b18
HUMAN OTC DRUG LABEL
May 12, 2025
WHITE GLO USA INC
DUNS: 117345666
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM MONOFLUOROPHOSPHATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Labeling:
INDICATIONS & USAGE SECTION
Use
helps protect against cavities
SPL UNCLASSIFIED SECTION
Other information
- Store in a cool place, below 86ºF, away from heat
- Do not use if quality seal is broken or missing
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).
Purpose
Anticavity toothpaste
WARNINGS SECTION
Warnings
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.
DOSAGE & ADMINISTRATION SECTION
Directions
|
Adults and children |
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.
INACTIVE INGREDIENT SECTION
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.
OTC - QUESTIONS SECTION
Questions or comments
For customer enquiries, please contact: hello@optimax.today
White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell, California, 95008. www.optimax.today