FDA label 45b09a50-dab4-e83d-e063-6394a90aa813

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
516801f7-ba4f-4716-bd1f-af4e322675b6
SPL ID
45b09a50-dab4-e83d-e063-6394a90aa813
Version
109
Effective date
2025-12-11
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:28:06

Warnings cross-check#

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warnings and cautions

WARNINGS: DO NOT SWALLOW Accidental ingestion of the usual treatment dose (approx 12.4 mg of fluoride) is not harmful. In the event more than the treatment dose is swallowed, administer calcium (e.g. milk) and get medical or contact a Poison control Center right away. One bottle of Minute Foam contained 1.95 grams of fluoride ion which could be lethal for children adults. Keep out of the reach of infants and children under 12 years. Pediatric patients under age 12 should be supervised during use of this product. Avoid spraying towards open flame. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures over 120 F (49 C). PRECAUTIONS: FOR PROFESSIONAL USE ONLY Laboratory studies have indicated that repeated use of Acidulated Phosphate Fluoride products may dull porcelain and composite restorations. Safety and effectiveness below age 6 have not been established. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness