DailyMed - DailyMed Details

SPL v3

SPL

SPL Set ID 249cc46a-dad6-0345-e063-6394a90a4447

Route

DENTAL

Published

Effective Date 2024-10-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 mg)

Inactive Ingredients

Flavor Spice Mint N&a110589 Zinc Citrate Fd&c Blue No. 1 Sodium Hydroxide Sodium Lauryl Sulfate Water Xylitol Poloxamer 407 Sodium Pyrophosphate Sodium Benzoate Xanthan Gum Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Glycerin Sucralose Silicon Dioxide Fd&c Yellow No. 5 Sorbitol

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2024-10-21 Until 2027-08-14

Description

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Description

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Structured Label Content

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "FLAVOR SPICE MINT N&A110589", "unii": "KG6KU384XW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC CITRATE", "unii": "K72I3DEX9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PYROPHOSPHATE", "unii": "O352864B8Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34071-1": "Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:19.681838 · Updated: 2026-03-14T23:09:03.764166