Ipana Wintergreen Fluoride Paste
FDA Label NDC 69510-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maxill Inc. for the product Ipana Wintergreen Fluoride (NDC 69510-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, use, warnings, keep out of reach of children under 6 years of age., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities.
Warnings
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.
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
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
Label (Label)
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