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

Purpose

Anticavity

Description

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

Medication Information

Warnings

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.

Inactive Ingredients

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

Description

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

Use

Aids in the prevention of dental cavities.

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)

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

Warnings

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.

Inactive Ingredients

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

Use

Aids in the prevention of dental cavities.

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)

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