Priyal Toothpaste

Priyal Toothpaste
SPL v1
SPL
SPL Set ID aa54fa9c-7e2d-8bab-e053-2995a90afaa7
Route
DENTAL
Published
Effective Date 2013-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Saccharin Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-27

Description

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste


Medication Information

Warnings and Precautions

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately

Purpose

Anticavity toothpaste

Description

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Uses

aids in the prevention of dental cavities

Warning

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

Directions

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 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 ■ children under 6 years of age: do not use unless directed by a doctor or dentist

Package Label

Active Ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose,Flavor, sodium saccharin, sodium methylparaben, sodium propylparaben


Structured Label Content

Uses

aids in the prevention of dental cavities

Warnings and Precautions (34071-1)

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately

Purpose

Anticavity toothpaste

Warning

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

Directions

■ do not swallow ■ supervise children as necessary until capable of using without supervision ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ adults and children 6 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 ■ children under 6 years of age: do not use unless directed by a doctor or dentist

Package Label

Active Ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose,Flavor, sodium saccharin, sodium methylparaben, sodium propylparaben


Advanced Ingredient Data


Raw Label Data

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