FDA.reportPublic FDA data

Fascy Moisture Bomb Hand Strawberry 40mL

Manufacturer
FASCY Co,.LTD. | WELCOS CO.,LTD.
Effective date
2017-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:12

Label at a glance#

ProductFascy Moisture Bomb Hand Strawberry 40mL
Active ingredientDimethicone
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dimethicone 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Glycerin, Cetearyl Alcohol, Mineral Oil, Dipropylene Glycol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Sorbitan Stearate, Sodium Polyacrylate, Ethylhexyl Stearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Butylene Glycol, Potassium Hydroxide, Trideceth-6, Butyrospermum Parkii (Shea) Butter, Panthenol, Fragaria Chiloensis (Strawberry) Fruit Extract, Allantoin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, CI 17200, CI 19140, CI 14700, Fragrance

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only. When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns. Keep out of reach of children. Do not keep it in direct sunlight, high or low temperature.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

How to use

INDICATIONS & USAGE SECTION

How to use: Apply desired amount and massage into the hands.

How to use

DOSAGE & ADMINISTRATION SECTION

How to use: Apply desired amount and massage into the hands.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116731dimethicone 4 % Topical CreamPSN1
1116731dimethicone 40 MG/ML Topical CreamSCD1
1116731dimethicone 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809392416626GTIN-13: 8809392416626
EAN-13: 8809392416626
GTIN storage (14 digits): 08809392416626		fascy moisture bomb hand cream strawberry carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70991-080-022020-01-31C16284748780-19d75b9cf-fd19-f424-e053-dadaa90a57ce3c0b5a0e-8fa7-454c-80b3-7e7bce89be4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70991-080-01Fascy Moisture Bomb Hand Strawberry 40mL40 mL in 1 TUBECREAM401
70991-080-02Fascy Moisture Bomb Hand Strawberry 40mL1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70991-080FASCY MOISTURE BOMB HAND STRAWBERRY 40ML (DIMETHICONE) CREAM [FASCY CO,.LTD.]1Legacy NDC, 2 package rows20170310_3c0b5a0e-8fa7-454c-80b3-7e7bce89be4a.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
70991-08070991-080-01, 70991-080-02

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
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT

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
2afbf1df-cc7a-4471-ac84-2b0247b7934c3c0b5a0e-8fa7-454c-80b3-7e7bce89be4a2017-03-10WarningsExact identifier
spl id: 2afbf1df-cc7a-4471-ac84-2b0247b7934c
spl set id: 3c0b5a0e-8fa7-454c-80b3-7e7bce89be4a

Reported adverse events (FAERS/openFDA)#

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