249cc46a-dad6-0345-e063-6394a90a4447

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

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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