FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Mi Amore Skincare, LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:26

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6 use only under adult supervision
  • not recommended for infants

WARNINGS SECTION

For External Use Only

Flammable, keep away from fire or flame

INACTIVE INGREDIENT SECTION

organic coconut oil, organic olive oil, organic jojoba oil, lavender essential oil, orange essential oil, cedarwood oil, rosemary extract, organic aloe vera.

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin
  • recommended for repeated use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand SanitizerHand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014638isopropyl alcohol 70 % Topical SprayPSN4
1014638isopropyl alcohol 0.7 ML/ML Topical SpraySCD4
1014638isopropyl alcohol 70 % Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73770-810-012024-12-13C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006
73770-810-042024-12-13C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006
73770-810-052024-12-13C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006
73770-810-012022-01-28C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006
73770-810-042022-01-28C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006
73770-810-052022-01-28C16284748780-1d6a99b39-6ea4-a426-e053-dadaa90af4c2a0eed4e6-e604-cc28-e053-2995a90a9006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73770-810-01Hand Sanitizer59 mL in 1 BOTTLE, SPRAYSPRAY594
73770-810-04Hand Sanitizer120 mL in 1 BOTTLE, SPRAYSPRAY1204
73770-810-05Hand Sanitizer150 mL in 1 BOTTLE, SPRAYSPRAY1504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73770-810HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY [MI AMORE SKINCARE, LLC]4Legacy NDC, 3 package rows20241215_a0eed4e6-e604-cc28-e053-2995a90a9006.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
73770-81073770-810-01, 73770-810-05, 73770-810-04

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
JOJOBA OIL724GKU717MIACT
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
BITTER ORANGE OIL9TLV70SV6IIACT
CEDAR LEAF OILBJ169U4NLGIACT
SUNFLOWER OIL MONOGLYCERIDESZVW8EIZ3IEIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
LAVENDER OILZBP1YXW0H8IACT
ROSEMARY OIL8LGU7VM393IACT

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
292e4b85-bb75-0e23-e063-6394a90af36ea0eed4e6-e604-cc28-e053-2995a90a90062024-12-13WarningsExact identifier
spl id: 292e4b85-bb75-0e23-e063-6394a90af36e
spl set id: a0eed4e6-e604-cc28-e053-2995a90a9006

Reported adverse events (FAERS/openFDA)#

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