Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 72f42d51-933a-687e-e053-2991aa0a5f3b
Route
TOPICAL
Published
Effective Date 2018-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.5 g)
Inactive Ingredients
Water Citric Acid Monohydrate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-09-01
Description

Active Ingredients Glycerin USP 50%

Medication Information

Description

Active Ingredients Glycerin USP 50%

Use
  • for oral care associated with mouth and postoperative mouth care
  • for dry mouth relief
Section 50565-1

In case of accidental overdose , get medical help or contact a Poison Control Center right away

Section 51945-4

Section 55105-1

Purpose

Oral Demulcent

Section 55106-9

Active Ingredients

Glycerin USP 50%

Warnings
  • Do not use in the eyes

Directions

  • swab mouth as needed
  • discard after single use
Other Information

  • Store at room temperature 15 o-30 o C (59 o-86 o F)
  • avoid excessive heat

Inactive Ingredients

Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

Stop Use and Ask A Doctor If
  • If irritation and redness develops
  • the condition persists more than 72 hours

Structured Label Content

Use (USE)
  • for oral care associated with mouth and postoperative mouth care
  • for dry mouth relief
Section 50565-1 (50565-1)

In case of accidental overdose , get medical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral Demulcent

Section 55106-9 (55106-9)

Active Ingredients

Glycerin USP 50%

Warnings (warnings)
  • Do not use in the eyes

Directions

  • swab mouth as needed
  • discard after single use
Other Information

  • Store at room temperature 15 o-30 o C (59 o-86 o F)
  • avoid excessive heat

Inactive Ingredients

Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)
  • If irritation and redness develops
  • the condition persists more than 72 hours

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.757807 · Updated: 2026-03-14T22:55:14.803903