Gynex Monsels

SPL v4

SPL

SPL Set ID 26408e81-f131-15ca-e063-6394a90a6fb6

Route

TOPICAL

Published

Effective Date 2025-02-18

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ferric Cation (210 mg)

Inactive Ingredients

Silicon Dioxide Sodium Benzoate Ferric Sulfate Water

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2024-11-29

Description

Ferric Subsulfate 20-22% by weight

Medication Information

Dosage and Administration

Do not reuse, discard after one use.

Description

Ferric Subsulfate 20-22% by weight

Section 44425-7

Store at room temperature (15-30degC)

Keep cap tightly sealed

Protect from light

Mfg. for and distrib. by:

Gynex

North Richland Hills, TX

Section 51727-6

Other Ingredients include thickeners, preservatives, and purified water

Section 51945-4

NDC 48783-113-08

Gynex Monsel's Ferric Subsulfate Paste

REF 5055

Monsel's Ferric Subsulfate Paste 20-22%, Non-Sterile, Single-Patient Use

12 single applications - 8mL vials, 12 rayon-tipped applicators

Section 55106-9

Ferric Subsulfate 20-22% by weight

Structured Label Content

Dosage and Administration (34068-7)

Do not reuse, discard after one use.

Section 44425-7 (44425-7)

Store at room temperature (15-30degC)

Keep cap tightly sealed

Protect from light

Mfg. for and distrib. by:

Gynex

North Richland Hills, TX

Section 51727-6 (51727-6)

Other Ingredients include thickeners, preservatives, and purified water

Section 51945-4 (51945-4)

NDC 48783-113-08

Gynex Monsel's Ferric Subsulfate Paste

REF 5055

Monsel's Ferric Subsulfate Paste 20-22%, Non-Sterile, Single-Patient Use

12 single applications - 8mL vials, 12 rayon-tipped applicators

Section 55106-9 (55106-9)

Ferric Subsulfate 20-22% by weight

Advanced Ingredient Data

[{"name": "FERRIC CATION", "unii": "91O4LML611", "classCode": "ACTIM", "strengthNumerator": "210", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC SULFATE", "unii": "3HWS7HF5XD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34068-7": "Do not reuse, discard after one use.", "44425-7": "Store at room temperature (15-30degC) Keep cap tightly sealed Protect from light Mfg. for and distrib. by: Gynex North Richland Hills, TX", "51727-6": "Other Ingredients include thickeners, preservatives, and purified water", "51945-4": "NDC 48783-113-08 Gynex Monsel's Ferric Subsulfate Paste REF 5055 Monsel's Ferric Subsulfate Paste 20-22%, Non-Sterile, Single-Patient Use 12 single applications - 8mL vials, 12 rayon-tipped applicators", "55106-9": "Ferric Subsulfate 20-22% by weight"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:52:12.497805 · Updated: 2026-03-14T22:43:02.315476