FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Raining Rose, Inc
Effective date
2021-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:37

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70%

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

WARNINGS SECTION

Warnings• For external use only
• Flammable, keep away from fire or flame
• Do not use in eyes. In case of eye contact flush
thoroughly with water and seek medical attention.

• Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
• Dispense an adequate amount in your palm to cover all surfaces of hands completely.

• Rub hands together until dry. • Does not require rinsing.

OTHER SAFETY INFORMATION

Other Information
• Do not store above 105°F.
• May discolor some fabrics.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Vanilla Fragrance, Acrylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10886 Combined-01C10886 Combined-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65692-2064-12023-01-30C16284748780-1f386c649-e586-0266-e053-dadaa90a7c1abc44c2cb-0b21-ea6d-e053-2995a90a41bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-2064-1Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-2064HAND SANITIZER GEL [RAINING ROSE, INC]1Legacy NDC, 1 package rows20210227_bc44c2cb-0b21-ea6d-e053-2995a90a41bd.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-206465692-2064-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
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
bc44c2cb-0b16-ea6d-e053-2995a90a41bdbc44c2cb-0b21-ea6d-e053-2995a90a41bd2021-02-26WarningsExact identifier
spl id: bc44c2cb-0b16-ea6d-e053-2995a90a41bd
spl set id: bc44c2cb-0b21-ea6d-e053-2995a90a41bd

Reported adverse events (FAERS/openFDA)#

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