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

Description

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

Uses

Aids in the prevention of dental cavities.

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.

Questions

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

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.
Active Ingredient

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

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.

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

Uses (USES)

Aids in the prevention of dental cavities.

Purpose (PURPOSE)

Anticavity

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.

Questions (QUESTIONS)

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

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.
Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate (0.14% w/v fluoride ion)

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.

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

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