37eeb656-22f1-7372-e063-6394a90ad041

SPL v1

SPL

SPL Set ID 37eeb656-22f1-7372-e063-6394a90ad041

Route

dental

Published

Effective Date 2025-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

water (1 g) sorbitol

Inactive Ingredients

ci 45410 hydrated silica sodium lauryl sulfate flavor spice mint n&a110589 polyglyceryl-10 laurate sucralose glycerin peg-40 lanolin xanthan gum sodium benzoate acesulfame potassium

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2025-06-24

Description

hydrated silica,glycerin,CI 45410,xanthan gum,sodium lauryl sulfate,sodium benzoate,flavor,polyglyceryl-10 laurate,acesulfame potassium,sucralose

Medication Information

Warnings and Precautions

Do not swallow directly

Active Ingredient

sorbitol,water

Indications and Usage

Apply directly to a toothbrush to clean your mouth

Dosage and Administration

60g

Description

hydrated silica,glycerin,CI 45410,xanthan gum,sodium lauryl sulfate,sodium benzoate,flavor,polyglyceryl-10 laurate,acesulfame potassium,sucralose

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6

hydrated silica,glycerin,CI 45410,xanthan gum,sodium lauryl sulfate,sodium benzoate,flavor,polyglyceryl-10 laurate,acesulfame potassium,sucralose

Section 51945-4

Section 55105-1

Clean your teeth

Structured Label Content

Warnings and Precautions (34071-1)

Do not swallow directly

Active Ingredient (55106-9)

sorbitol,water

Indications and Usage (34067-9)

Apply directly to a toothbrush to clean your mouth

Dosage and Administration (34068-7)

60g

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6 (51727-6)

hydrated silica,glycerin,CI 45410,xanthan gum,sodium lauryl sulfate,sodium benzoate,flavor,polyglyceryl-10 laurate,acesulfame potassium,sucralose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Clean your teeth

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CI 45410", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLAVOR SPICE MINT N&A110589", "unii": "KG6KU384XW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-10 LAURATE", "unii": "MPJ2Q8WI8G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-40 LANOLIN", "unii": "419118M77O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply directly to a toothbrush to clean your mouth", "34068-7": "60g", "34071-1": "Do not swallow directly", "50565-1": "KEEP OUT OF REACH OF CHILDREN SECTION", "51727-6": "hydrated silica,glycerin,CI 45410,xanthan gum,sodium lauryl sulfate,sodium benzoate,flavor,polyglyceryl-10 laurate,acesulfame potassium,sucralose", "55105-1": "Clean your teeth", "55106-9": "sorbitol,water"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:12:04.705393 · Updated: 2026-03-14T23:17:27.453851