FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Raining Rose | Aire-Master America, Inc
Effective date
2021-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:12

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

For external use only. Flammable, keep away from fire or flame. Do not use in or near 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. 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

DOSAGE & ADMINISTRATION SECTION

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

Do not store above 100 degrees F. May discolor some fabrics.

INACTIVE INGREDIENT SECTION

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

C10888 Combined-01C10888 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
65692-2071-12023-01-30C16284748780-1f386c64a-47fa-0266-e053-dadaa90a7c1ac1aa9b93-e862-b1f4-e053-2a95a90af2b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-2071-1Hand Sanitizer14.8 mL in 1 BOTTLE, PLASTICGEL14.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-2071HAND SANITIZER GEL [RAINING ROSE]1Legacy NDC, 1 package rows20210507_c1aa9b93-e862-b1f4-e053-2a95a90af2b3.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
65692-207165692-2071-1

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
GLYCERINPDC6A3C0OXIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT

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
c1aa9b93-e863-b1f4-e053-2a95a90af2b3c1aa9b93-e862-b1f4-e053-2a95a90af2b32021-05-06WarningsExact identifier
spl id: c1aa9b93-e863-b1f4-e053-2a95a90af2b3
spl set id: c1aa9b93-e862-b1f4-e053-2a95a90af2b3

Reported adverse events (FAERS/openFDA)#

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