FDA.reportPublic FDA data

BP

Manufacturer
MIGUHARA
Effective date
2016-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:04

Label at a glance#

ProductBP
Active ingredientCYCLOMETHICONE 5
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Cyclopentasiloxane 12%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Dimethicone/Vinyl Dimethicone Crosspolymer , Cyclohexasiloxane, Laureth-23, Sodium Polyacrylate, Ethylhexyl Stearate, Trideceth-6, Polymethyl Methacrylate, Polymethylsilsesquioxane, Ethylhexyl Palmitate, Prunus Armeniaca (Apricot) Kernel Oil, Macadamia Integrifolia Seed Oil, Helianthus Annuus (Sunflower) Seed Oil , Titanium dioxide, Yellow Iron Oxide, Red Iron Oxide, Black Iron Oxide, Tocopheryl Acetate, Retinyl Palmitate, Jasmine Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. be aware not to get in eyes.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Usage

INDICATIONS & USAGE SECTION

Usage: Take an appropriate amount and gently apply it until absorbed.

Usage

DOSAGE & ADMINISTRATION SECTION

Usage: Take an appropriate amount and gently apply it until absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70380-140-012020-01-31C16284748780-19d75b9d0-a393-f424-e053-dadaa90a57ce9fb77f9b-120c-4c76-907a-71ded81a0040

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70380-140-01BP30 mL in 1 CARTONCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70380-140BP (CYCLOMETHICONE 5) CREAM [MIGUHARA]1Legacy NDC, 1 package rows20160219_9fb77f9b-120c-4c76-907a-71ded81a0040.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70380-14070380-140-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RACTIB
Laureth-23N72LMW566GIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT

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
a0b521a7-d2a5-4143-949a-1894d2d672529fb77f9b-120c-4c76-907a-71ded81a00402016-02-19WarningsExact identifier
spl id: a0b521a7-d2a5-4143-949a-1894d2d67252
spl set id: 9fb77f9b-120c-4c76-907a-71ded81a0040

Reported adverse events (FAERS/openFDA)#

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