FDA label 71a7a688-42e3-4bff-bcb1-1d2caede4328

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: 989b482a-7504-4261-99dc-51654890385e
SPL ID: 71a7a688-42e3-4bff-bcb1-1d2caede4328
Version: 2
Effective date: 2016-09-12
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:22:25

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		71a7a688-42e3-4bff-bcb1-1d2caede4328	id
spl set id		989b482a-7504-4261-99dc-51654890385e	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Pediatric patients under 12 years of age should be supervised in the use of this product. Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 requires special supervision to prevent repeated swallowing of rinse. Do not use before mixing with water. This product may produce temporary surface staining of teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Read directions carefully before using. Keep out of reach of infants and children.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies are rarely reported.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.