FDA.reportPublic FDA data

Hand Sanitizer gel

Manufacturer
RFH BioTek Inc.
Effective date
2022-07-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:20

Label at a glance#

ProductHand Sanitizer gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in palm to cover hands. Rub briskly until dry. Supervise children under 6 years of age.

Storage and handling

Store in a cool, dry place, keep away from direct sunlight. Store between 15-30C (59-86F). Avoid Freezing and excess heat above 40C (104F).

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USE

INDICATIONS & USAGE SECTION

This rinse-free hand gel moisturizes the hands while cleaning and helps to reduce bacteria that potentially can cause disease.

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. Avoid contact with broken skin.

WHEN USING THIS PRODUCTS

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 appears and lasts.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Put enough product in palm to cover hands. Rub briskly until dry. Supervise children under 6 years of age.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store in a cool, dry place, keep away from direct sunlight. Store between 15-30C (59-86F). Avoid Freezing and excess heat above 40C (104F).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, SILVER.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER

GEL WITH pure SILVER

  • Cleans & care for hands
  • Provides moisture & refreshes
  • Dries fast and is not sticky
  • Improves hand hygiene by reducing bacteriria

MicroSilver

BG™

99.99%

ANTIBACTERIAL

1. 50 ML1. 50 ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78994-070-012025-01-30C16284748780-1e4f33bdf-a7a8-d8a0-e053-dadaa90a6e4eHAND SANITIZER GEL WITH pure SILVER - Alcohol gel
78994-070-012022-08-04C16284748780-1e4f33bdf-a7a8-d8a0-e053-dadaa90a6e4eHAND SANITIZER GEL WITH pure SILVER - Alcohol gel
78994-070-012022-07-29C16284748780-1e4f33bdf-a7a8-d8a0-e053-dadaa90a6e4eHAND SANITIZER GEL WITH pure SILVER - Alcohol gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78994-070-01Hand Sanitizer gel50 mL in 1 BOTTLE, PLASTICGEL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78994-070HAND SANITIZER GEL (ALCOHOL) GEL [RFH BIOTEK INC.]3Legacy NDC, 1 package rows20220805_a8345ce0-c378-b907-e053-2995a90a506f.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
78994-07078994-070-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
SILVER3M4G523W1GIACT
ALCOHOL3K9958V90MACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
e443b0d5-be7f-59c9-e053-2a95a90a28fea8345ce0-c378-b907-e053-2995a90a506f2022-07-20WarningsExact identifier
spl id: e443b0d5-be7f-59c9-e053-2a95a90a28fe
spl set id: a8345ce0-c378-b907-e053-2995a90a506f

Reported adverse events (FAERS/openFDA)#

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