Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID edee14da-13d8-4bc2-9c37-cfc353763d11

Route

TOPICAL

Published

Effective Date 2017-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Glycerin (500 mg)

Inactive Ingredients

Water Citric Acid Monohydrate Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-01

Description

Active Ingredients Glycerin USP 50%

Medication Information

Warnings and Precautions

Indications and Usage

Use

For oral care post operatively and for swabbing whenever special mouth care is prescribed

Dosage and Administration

Directions

Swab mouth as needed. Discard after single use.

Description

Active Ingredients Glycerin USP 50%

Section 44425-7

Other Information

Store at room temperature 15 -30 C (59 -86 F) ^o ^o ^o ^o

Section 50565-1

Keep out reach of children

If swallowed, get medical help or contact Poison Control Center right away

Section 51727-6

Inactive Ingredients

Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredients

Glycerin USP 50%

Do Not Use

If pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

Package Label

Structured Label Content

Indications and Usage (34067-9)

Use

For oral care post operatively and for swabbing whenever special mouth care is prescribed

Dosage and Administration (34068-7)

Directions

Swab mouth as needed. Discard after single use.

Warnings and Precautions (34071-1)

Section 44425-7 (44425-7)

Other Information

Store at room temperature 15 -30 C (59 -86 F) ^o ^o ^o ^o

Section 50565-1 (50565-1)

Keep out reach of children

If swallowed, get medical help or contact Poison Control Center right away

Section 51727-6 (51727-6)

Inactive Ingredients

Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredients

Glycerin USP 50%

Do Not Use

If pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

Package Label

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use For oral care post operatively and for swabbing whenever special mouth care is prescribed", "34068-7": "Directions Swab mouth as needed. Discard after single use.", "44425-7": "Other Information Store at room temperature 15 -30 C (59 -86 F) o o o o", "50565-1": "Keep out reach of children If swallowed, get medical help or contact Poison Control Center right away", "51727-6": "Inactive Ingredients Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate", "55105-1": "Purpose Skin Protectant", "55106-9": "Active Ingredients Glycerin USP 50%", "Do Not Use": "If pain, irritation, redness, or swelling occurs, discontinue use and consult a physician."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:16.507588 · Updated: 2026-03-14T23:12:26.991151