FDA.reportPublic FDA data

Monistat Chafing Gel

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:11:07

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
NET WT/ Peso Neto 1.5 oz (42g)

MONISTAT Care® Chafing Relief Powder Gel® DIMETHICONE /SKIN PROTECTANT NET WT/ Peso Neto 1.5 oz (42g)MONISTAT Care® Chafing Relief Powder Gel® DIMETHICONE /SKIN PROTECTANT NET WT/ Peso Neto 1.5 oz (42g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
706952dimethicone 1.2 % Topical GelPSN5
1117398MONISTAT COMPLETE CARE Chafing Relief 1.2 % Topical GelPSN5
1117398dimethicone 0.012 MG/MG Topical Gel [Monistat Soothing Care]SBD5
706952dimethicone 0.012 MG/MG Topical GelSCD5
706952dimethicone 1.2 % Topical GelSY5
1117398Monistat Soothing Care 0.012 MG/MG Topical GelSY5
1117398Monistat Soothing Care Chafing Relief 1.2 % Topical GelSY5

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
63736-031-01Monistat Complete Care Chafing Relief42 g in 1 TUBEGEL425
63736-031-01Monistat Complete Care Chafing Relief1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-031MONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20240418_07d7c883-1fa3-4786-905c-a1fab649765e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1O1
dimethiconeACTIVE MOIETY92RU3N3Y1O1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
dimethicone/vinyl dimethicone crosspolymer (hard particle)INACTIVE INGREDIENTH895X08VNQ1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
trisiloxaneINACTIVE INGREDIENT9G1ZW13R0G1

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
63736-03163736-031-01

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates

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
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
ndc (package): 63736-031-01
ndc (product): 63736-031
ndc11 (package): 63736003101
spl id: 7298c9c8-609a-4f1e-967b-faf2d183aa77
spl set id: 07d7c883-1fa3-4786-905c-a1fab649765e

Reported adverse events (FAERS/openFDA)#

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