MONS GEL

Manufacturer
Pharmacal-International. Co., Ltd
Effective date
2023-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:22

Label at a glance#

ProductMONS
Active ingredientGLYCERIN, ALLANTOIN
Label structure6 sections

Dosage and administration

Apply liberally as needed, softly massage for absorption

Label contents#

Full prescribing information#

Active Ingredient                                       Purpose

OTC - ACTIVE INGREDIENT SECTION

GLYCERIN 8.0%------------------------- Skin protectant
ALLANTOIN 0.1%-----------------------  Skin protectant

Indication and Usage

INDICATIONS & USAGE SECTION

Apply the appropriate amount before and after exercising,
as if you are gently massaging your hands or vibration applications, on the areas you need,
except your face.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally as needed, softly massage for absorption

Warnings

WARNINGS SECTION

■ Do not use on dermatitis, damaged skin or eczema
■ Stop using and ask a doctor if rash, swelling, or irritation occurs
■ Keep out of reach of children
■ Follow the directions

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Inactive ingrdients

INACTIVE INGREDIENT SECTION

WATER,CAPRYLIC/CAPRIC TRIGLYCERIDE,POLYSORBATE 80,VANILLYL BUTYL,ETHER,ALCOHOL,BUTYLENE,GLYCOL,CARBOMER,TRIETHANOLAMINE,MENTHOL,ETHYLHEXYLGLYCERIN,CAPRYLYLGLYCOL,PROPYLENE,GLYCOL,POLYACRYLAMIDE,1,2-HEXANEDIOL,DIMETHYL SULFONE,ACETYL GLUCOSAMINE,C13-14 ISOPARAFFIN,TROPOLONE,PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT,FICUS CARICA (FIG) FRUIT EXTRACT,LAURETH-7,HYDROXYACETOPHENONE,CAPSICUM FRUTESCENS FRUIT EXTRACT,CENTELLA ASIATICA EXTRACT,OPUNTIA FICUS-INDICA EXTRACT,OPUNTIA COCCINELLIFERA FRUIT EXTRACT,ADANSONIA DIGITATA SEED EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,POLYGONUM CUSPIDATUM ROOT EXTRACT,SODIUM HYALURONATE,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,CAMELLIA SINENSIS LEAF EXTRACT,ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,PERILLA OCYMOIDES LEAF EXTRACT,ACORUS CALAMUS ROOT EXTRACT,DISODIUM EDTA,FRAGRANCE,BENZYL BENZOATE,CITRONELLOL,GERANIOL.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24765-125-012023-02-02C16284748780-1f386c64a-36db-0266-e053-dadaa90a7c1aMONS GEL
24765-125-012023-01-30C16284748780-1f386c64a-36db-0266-e053-dadaa90a7c1aMONS GEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24765-12524765-125-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
021e2371-16d5-37fb-e063-6394a90a0e811b3a9442-ca33-4d67-9962-76a67f85b58d2023-08-04WarningsExact identifier
spl set id: 1b3a9442-ca33-4d67-9962-76a67f85b58d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.