FDA.reportPublic FDA data

Amphora Aromatics Hand Sanitizer

Manufacturer
QINGDAO AMPHORA AROMATICS CO.,LTD
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:14

Label at a glance#

ProductAmphora Aromatics Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

· Put enough product in your palm to thoroughly cover your hands · Rub hands together briskly until dry Children under 6 years of age snould be supervised when using this product

Storage and handling

Store below 110F ( 43C ) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

· Hand Sanitizer to help reduce bacteria on the skin that could cause disease
· Recommended for re eated use

Warnings

WARNINGS SECTION

Flammable;Keep away from fire or flame.
For external use only.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask doctor if irritation or rash appears and lasts.

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

Do not use

OTC - DO NOT USE SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask doctor if irritation or rash appears and lasts.

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

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash appears and lasts.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

· Put enough product in your palm to thoroughly cover your hands
· Rub hands together briskly until dry
Children under 6 years of age snould be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

Store below 110F ( 43C )
May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water(Aqua),carbomer,glycerin,lemon oil,triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN3
1305100ethanol 0.75 ML/ML Topical GelSCD3
1305100ethanol 75 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75235-001-012021-07-23C16284748780-1c7ccaba7-1836-fd44-e053-dadaa90aa01b75235-001 Amphora Aromatics Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75235-001-01Amphora Aromatics Hand Sanitizer500 mL in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75235-001AMPHORA AROMATICS HAND SANITIZER (HAND SANITIZER) GEL [QINGDAO AMPHORA AROMATICS CO.,LTD]3Legacy NDC, 1 package rows20200915_a33c1124-16ed-6e67-e053-2a95a90ac3e4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75235-00175235-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LEMON OILI9GRO824LLIACT
CARBOMER 9404Q93RCW27EIACT

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
af41e165-be7e-b3de-e053-2a95a90a5c63a33c1124-16ed-6e67-e053-2a95a90ac3e42020-09-14WarningsExact identifier
spl id: af41e165-be7e-b3de-e053-2a95a90a5c63
spl set id: a33c1124-16ed-6e67-e053-2a95a90ac3e4

Reported adverse events (FAERS/openFDA)#

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