FDA.reportPublic FDA data

I FAM Skin Hand Sanitizer gel

Manufacturer
Rainbow Co Ltd
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:25

Label at a glance#

ProductI FAM Skin Hand Sanitizer gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

alcohol

INACTIVE INGREDIENT SECTION

WATER
DIPROPYLENE GLYCOL
CARBOMER
GLYCERIN
TRIETHANOLAMINE
PEG-60 HYDROGENATED CASTOR OIL
PANTHENOL
CAMELLIA SINENSIS LEAF EXTRACT
ALOE 8AR8ADENSIS LEAF EXTRACT
DIETHANOLAMINE
CITRUS PARADIS! (GRAPEFRUIT) PEEL OIL

OTC - PURPOSE SECTION

Sterilization of hands and skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

WARNINGS SECTION

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74247-0007-12021-07-23C16284748780-1c7ccaba7-1ede-fd44-e053-dadaa90aa01bDrug Facts
74247-0007-22021-07-23C16284748780-1c7ccaba7-1ede-fd44-e053-dadaa90aa01bDrug Facts
74247-0007-32021-07-23C16284748780-1c7ccaba7-1ede-fd44-e053-dadaa90aa01bDrug Facts
74247-0007-42021-07-23C16284748780-1c7ccaba7-1ede-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74247-0007-1I FAM Skin Hand Sanitizer gel500 mL in 1 BOTTLEGEL5002
74247-0007-2I FAM Skin Hand Sanitizer gel3 mL in 1 POUCHGEL32
74247-0007-3I FAM Skin Hand Sanitizer gel15 mL in 1 POUCHGEL152
74247-0007-4I FAM Skin Hand Sanitizer gel3785 mL in 1 BOTTLEGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74247-0007I FAM SKIN HAND SANITIZER GEL (ALCOHOL) GEL [RAINBOW CO LTD]2Legacy NDC, 4 package rows20200613_a34818cf-604a-0807-e053-2995a90ab81c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74247-000774247-0007-1, 74247-0007-2, 74247-0007-3, 74247-0007-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
GRAPEFRUIT PEEL3582N05Q44IACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
DIMETHICONE92RU3N3Y1OIACT
PANTHENOLWV9CM0O67ZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a7ee2ec5-eb74-3d11-e053-2a95a90a4224a34818cf-604a-0807-e053-2995a90ab81c2020-06-12WarningsExact identifier
spl id: a7ee2ec5-eb74-3d11-e053-2a95a90a4224
spl set id: a34818cf-604a-0807-e053-2995a90ab81c

Reported adverse events (FAERS/openFDA)#

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