FDA.reportPublic FDA data

Hard Rock Hotel Universal Orlando Hand Sanitizer Gel

Manufacturer
Carretta USA, Inc
Effective date
2020-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:01

Label at a glance#

ProductHard Rock Hotel Universal Orlando Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-83F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.Flammable.

Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears,and mouth. In case of contact with eyes,rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-83F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water,Glycerin,Propylene glycol,Carbomer,Aloe Vera Extract,Triethanolamine,Disodium Edta

SPL UNCLASSIFIED SECTION

*99.99% of most common germs.

Distributed by:Carretta USA, Inc.

1500 County Road 517, Ste. 210

Hackettstown, NJ 07840

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78828-116-012022-01-28C16284748780-1d6a99b39-75ad-a426-e053-dadaa90af4c2Hard Rock Hotel Universal Orlando Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78828-116-01Hard Rock Hotel Universal Orlando Hand Sanitizer Gel30 mL in 1 BOTTLEGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78828-116HARD ROCK HOTEL UNIVERSAL ORLANDO HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [CARRETTA USA, INC]1Legacy NDC, 1 package rows20200626_6ae217ca-4ca3-4b69-8b91-b68498c81e58.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78828-11678828-116-01

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
0b668ee8-376a-4a02-bd84-03217052eb586ae217ca-4ca3-4b69-8b91-b68498c81e582020-06-13WarningsExact identifier
spl id: 0b668ee8-376a-4a02-bd84-03217052eb58
spl set id: 6ae217ca-4ca3-4b69-8b91-b68498c81e58

Reported adverse events (FAERS/openFDA)#

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