FDA.reportPublic FDA data

REGAL CARE

Manufacturer
SERVICE TOOL COMPANY, L.L.C. | Taizhou Yadai Daily-Use Co., Ltd.
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:20

Label at a glance#

ProductREGAL CARE
Active ingredientALCOHOL
Label structure12 sections

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 (59-86F) 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

Use

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

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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 Center 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 (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, aminomethylpropanol, alpha-tocopherol acetate, carbomer 940, aloe vera leaf, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 78710-075-02

REGAL-CARETM​

# 20040

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

2 oz/ 60 mL

LabelLabel

78710-075-04

REGAL-CARETM

# 20055

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

4 oz/ 120 mL

Label 1Label 1

78710-075-08

REGAL-CARETM

# 20060

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

8 oz/ 250 mL - PUMP

Label 2Label 2

78710-075-17

REGAL-CARETM

# 20070

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

16.9 oz/ 500 mL - PUMP

Label 3Label 3

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
78710-075-022021-07-23C16284748780-1c7ccaba7-2667-fd44-e053-dadaa90aa01b8167fdaa-7116-4015-8a92-3e03ebdf4e37
78710-075-042021-07-23C16284748780-1c7ccaba7-2667-fd44-e053-dadaa90aa01b8167fdaa-7116-4015-8a92-3e03ebdf4e37
78710-075-082021-07-23C16284748780-1c7ccaba7-2667-fd44-e053-dadaa90aa01b8167fdaa-7116-4015-8a92-3e03ebdf4e37
78710-075-172021-07-23C16284748780-1c7ccaba7-2667-fd44-e053-dadaa90aa01b8167fdaa-7116-4015-8a92-3e03ebdf4e37

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78710-075-02REGAL CARE60 mL in 1 BOTTLEGEL601
78710-075-04REGAL CARE120 mL in 1 BOTTLEGEL1201
78710-075-08REGAL CARE250 mL in 1 BOTTLEGEL2501
78710-075-17REGAL CARE500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78710-075REGAL CARE (ALCOHOL) GEL [SERVICE TOOL COMPANY, L.L.C.]1Legacy NDC, 4 package rows20200607_8167fdaa-7116-4015-8a92-3e03ebdf4e37.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
78710-07578710-075-02, 78710-075-04, 78710-075-08, 78710-075-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT

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
f5089cdd-1058-4852-8ba7-a76910b0f6ed8167fdaa-7116-4015-8a92-3e03ebdf4e372020-06-04WarningsExact identifier
spl id: f5089cdd-1058-4852-8ba7-a76910b0f6ed
spl set id: 8167fdaa-7116-4015-8a92-3e03ebdf4e37

Reported adverse events (FAERS/openFDA)#

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