5900 Clear Mint, Gel Toothpaste, 0.6oz.

5900 Clear Mint, Gel Toothpaste, 0.6oz.
SPL v1
SPL
SPL Set ID 1be193b6-4c07-4f0a-e063-6394a90a32c7
Route
DENTAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (220 mg)
Inactive Ingredients
Peppermint Oil Sodium Benzoate Polyethylene Glycol 1450 Hydrated Silica Carboxymethylcellulose Sodium, Unspecified Water Sodium Lauryl Sulfate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-16

Description

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Use(s)

Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Ask a dentist or physician.

Label 5900

5900 Clear Mint, Gel Toothpaste

Label 5901

5901 Clear Mint, Gel Toothpaste

Label 5902

5902 Clear Mint, Gel Toothpaste

Label 5903

5903 Clear Mint, Gel Toothpaste

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Other Information

Store between 15º-35ºC (59º-95ºF)

Inactive Ingredients

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age


Structured Label Content

Use(s)

Helps protect against cavities

Purpose

Anticavity

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Ask a dentist or physician.

Label 5900

5900 Clear Mint, Gel Toothpaste

Label 5901

5901 Clear Mint, Gel Toothpaste

Label 5902

5902 Clear Mint, Gel Toothpaste

Label 5903

5903 Clear Mint, Gel Toothpaste

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Other Information

Store between 15º-35ºC (59º-95ºF)

Inactive Ingredients

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age


Advanced Ingredient Data


Raw Label Data

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