6398ae96-dd38-44da-bc34-1d4d4c4a78ca

SPL v3
SPL
SPL Set ID 6398ae96-dd38-44da-bc34-1d4d4c4a78ca
Route
dental
Published
Effective Date 2023-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.4 mg)
Inactive Ingredients
sorbitol glycerin calcium pyrophosphate water hydrated silica xylitol silicon dioxide hydroxyethyl cellulose (140 mpa.s at 5%) isoceteth-20 carboxymethylcellulose sodium mint sodium benzoate lactoperoxidase bovine potassium thiocyanate glucose oxidase lysozyme lactoferrin, bovine dextranase penicillium calcium lactate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2018-02-19

Purpose

Anticavity

Description

Sodium Monofluorophosphate (0.14% w/v fluoride ion)


Medication Information

Warnings

Keep out of the reach of children under 6 years of age.

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

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.
  • To minimize swallowing for children under 6, use a pea-size amount and supervise brushing until good habits are established. Children under 2 years ask a dentist or physician.
Other Information

Store at Room Temperature.

Inactive Ingredients

Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Dextranase, Calcium Lactate.

Description

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

Questions

Questions? Comments? Call toll-free: 1-877-522-5333

Active Ingredient

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

Keep Out of Reach of Children

Keep out of the reach of children under 6 years of age.

Package Label.principal Display Panel

SALIVEA DRY MOUTH CARE TOOTHPASTE

Soothing Mint

with Xylitol & Calcium


Structured Label Content

Warnings (WARNINGS)

Keep out of the reach of children under 6 years of age.

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

Uses (USES)

Aids in the prevention of dental cavities.

Purpose (PURPOSE)

Anticavity

Directions (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.
  • To minimize swallowing for children under 6, use a pea-size amount and supervise brushing until good habits are established. Children under 2 years ask a dentist or physician.
Other Information (OTHER INFORMATION)

Store at Room Temperature.

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Dextranase, Calcium Lactate.

Questions (QUESTIONS)

Questions? Comments? Call toll-free: 1-877-522-5333

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

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

Keep out of the reach of children under 6 years of age.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

SALIVEA DRY MOUTH CARE TOOTHPASTE

Soothing Mint

with Xylitol & Calcium


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)