DailyMed - DailyMed Details

SPL v7

SPL

SPL Set ID 46f3b20e-1ed9-0d1e-e054-00144ff88e88

Route

DENTAL

Published

Effective Date 2016-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Azadirachta Indica Bark (1 [hp_X]) Calendula Officinalis Flower Echinacea Purpurea Plantago Major

Inactive Ingredients

Mentha Piperita Leaf Citric Acid Monohydrate Glycerin Peppermint Oil Polysorbate 20 Potassium Sorbate Xylitol Water Allantoin Propolis Wax

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2019-02-08

Medication Information

Section 50565-1

Section 50569-3

Section 55105-1

Recovery Kit, Gel, Rinse

Gel Principle Display Panel

Recovery Kit, Gel, Rinse, Spay

Rinse Gel Principle Display Panel

Recovery Kit Principal Display Panel

Spray Rinse Gel Principle Display Panel

Recovery Kit, Gel, Spray, Rinse Warning Section

Recovery Kit, Gel, Rinse, Spray Inactive Ingredient

Recovery Kit, Gel, Spray, Rinse Indications and Usage

Recovery Kit Consists of Rinse, Gel, Spray Active Ingredients

Structured Label Content

Section 50565-1 (50565-1)

Section 50569-3 (50569-3)

Section 55105-1 (55105-1)

Recovery Kit, Gel, Rinse (Recovery kit, gel, rinse)

Gel Principle Display Panel

Recovery Kit, Gel, Rinse, Spay

Rinse Gel Principle Display Panel

Recovery Kit Principal Display Panel

Spray Rinse Gel Principle Display Panel

Recovery Kit, Gel, Spray, Rinse Warning Section (Recovery kit, gel, spray, rinse warning section)

Recovery Kit, Gel, Rinse, Spray Inactive Ingredient (Recovery kit, gel, rinse, spray inactive ingredient)

Recovery Kit, Gel, Spray, Rinse Indications and Usage (recovery kit, gel, spray, rinse indications and usage)

Recovery Kit Consists of Rinse, Gel, Spray Active Ingredients (Recovery Kit consists of Rinse, Gel, Spray active ingredients)

Advanced Ingredient Data

[{"name": "MENTHA PIPERITA LEAF", "unii": "A389O33LX6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPOLIS WAX", "unii": "6Y8XYV2NOF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AZADIRACHTA INDICA BARK", "unii": "G580B439YI", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ECHINACEA PURPUREA", "unii": "QI7G114Y98", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PLANTAGO MAJOR", "unii": "W2469WNO6U", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:12:10.963902 · Updated: 2026-03-14T23:17:35.615715