Ipana Wintergreen Fluoride

SPL v9

SPL

SPL Set ID 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0

Route

DENTAL

Published

Effective Date 2014-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 g)

Inactive Ingredients

Calcium Carbonate Water Sorbitol Hydrated Silica Glycerin Sodium Lauryl Sulfate Sodium Pyrophosphate Carboxymethylcellulose Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-31 Until 2029-07-31

Description

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Use

Aids in the prevention of dental cavities.

Warnings

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years: Consult a dentist or doctor.

Drug Facts

Product Label

ipana

Since 1901

Wintergreen

FLUORIDE

TOOTHPASTE

FIGHTS CAVITIES

NET WT. 0.66 OZ (19g)

ITEM 40515

Dist. by:

Maxill inc.

Cortland, OH, USA 44410

1-800-268-8633 www.maxill.com

Made in Malaysia

Active Ingredients

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Inactive Ingredients

calcium carbonate, water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxymethylcellulose, sodium benzoate, sodium saccharin

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only.

Structured Label Content

Use

Aids in the prevention of dental cavities.

Purpose

Anticavity

Warnings

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years: Consult a dentist or doctor.

Drug Facts

Product Label

ipana

Since 1901

Wintergreen

FLUORIDE

TOOTHPASTE

FIGHTS CAVITIES

NET WT. 0.66 OZ (19g)

ITEM 40515

Dist. by:

Maxill inc.

Cortland, OH, USA 44410

1-800-268-8633 www.maxill.com

Made in Malaysia

Active Ingredients

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Inactive Ingredients

calcium carbonate, water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxymethylcellulose, sodium benzoate, sodium saccharin

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities.", "Purpose": "Anticavity", "Directions": "Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years: Consult a dentist or doctor.", "Product Label": "ipana Since 1901 Wintergreen FLUORIDE TOOTHPASTE FIGHTS CAVITIES NET WT. 0.66 OZ (19g) ITEM 40515 Dist. by: Maxill inc. Cortland, OH, USA 44410 1-800-268-8633 www.maxill.com Made in Malaysia", "Active Ingredients": "Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)", "Inactive Ingredients": "calcium carbonate, water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxymethylcellulose, sodium benzoate, sodium saccharin", "Keep out of reach of children under 6 years of age.": "If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:37.950429 · Updated: 2026-03-14T23:09:31.593516