FDA.reportPublic FDA data

Monistat Chafing Gel

Manufacturer
Apex International Mfg., LLC
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:59

Label at a glance#

ProductMonistat Complete Care Chafing Relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Monistat Care Chafing Relief Powder Gel®

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chafed, chapped or cracked skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

OTHER SAFETY INFORMATION

Store at 20˚-25˚C (68˚-77˚F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cyclomethicone, dimethicone, dimethicone/vinyl dimethicone crosspolymer, silica dimethyl silylate, vinyl dimethicone/methicone silsesquioxane crosspolymer 

Questions?

OTC - QUESTIONS SECTION

1-877-666-4782 Monistat.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONISTAT
Care®
Chafing Relief
Powder Gel®
Dimethicone/Skin Protectant
Dimeticona / Protector Para La Piel
NET WT / PESA NETO 1.5 oz (42g)

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
706952dimethicone 1.2 % Topical GelPSN1
1117398MONISTAT COMPLETE CARE Chafing Relief 1.2 % Topical GelPSN1
1117398dimethicone 0.012 MG/MG Topical Gel [Monistat Soothing Care]SBD1
706952dimethicone 0.012 MG/MG Topical GelSCD1
706952dimethicone 1.2 % Topical GelSY1
1117398Monistat Soothing Care 0.012 MG/MG Topical GelSY1
1117398Monistat Soothing Care Chafing Relief 1.2 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57501-087-01Monistat Complete Care Chafing Relief42 g in 1 TUBEGEL421
57501-087-01Monistat Complete Care Chafing Relief1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57501-087MONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [APEX INTERNATIONAL MFG., LLC]12 package rows20240622_ee8d88f9-68bd-4f8d-99d2-0f2ad3df6b52.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57501-08757501-087-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT

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
ab463c13-a338-4008-93b5-72d90fd94593ee8d88f9-68bd-4f8d-99d2-0f2ad3df6b522024-06-18WarningsExact identifier
spl id: ab463c13-a338-4008-93b5-72d90fd94593
spl set id: ee8d88f9-68bd-4f8d-99d2-0f2ad3df6b52

Reported adverse events (FAERS/openFDA)#

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