FDA.reportPublic FDA data

MyRemede Hand Sanitizer

Manufacturer
Remede Organics, Inc.
Effective date
2020-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:53

Label at a glance#

ProductMyRemede Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduse bacteria that potentially can cause disease. For use when stop 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

  • in 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 consult 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  dyr.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information 

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (water), glycerin, carbomer, propylene glycol, sodium hydroxide, parfum (fragrance), aloe barbadensis leaf extract

Package Labeling 100 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LableLable

Package Labeling 280ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lable2 Lable2Lable2

Package Labeling 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lable3Lable3

Package Labeling 2000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lable4Lable4

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
77529-000-032022-01-28C16284748780-1d6a99b39-a5c6-a426-e053-dadaa90af4c2MyRemede Hand Sanitizer
77529-000-092022-01-28C16284748780-1d6a99b39-a5c6-a426-e053-dadaa90af4c2MyRemede Hand Sanitizer
77529-000-162022-01-28C16284748780-1d6a99b39-a5c6-a426-e053-dadaa90af4c2MyRemede Hand Sanitizer
77529-000-672022-01-28C16284748780-1d6a99b39-a5c6-a426-e053-dadaa90af4c2MyRemede Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77529-000-03MyRemede Hand Sanitizer100 mL in 1 BOTTLEGEL1001
77529-000-09MyRemede Hand Sanitizer280 mL in 1 BOTTLEGEL2801
77529-000-16MyRemede Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77529-000-67MyRemede Hand Sanitizer2000 mL in 1 BOTTLEGEL20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77529-000MYREMEDE HAND SANITIZER (ALCOHOL) GEL [REMEDE ORGANICS, INC.]1Legacy NDC, 4 package rows20200512_a56a8c80-0d50-bd38-e053-2a95a90a51d6.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
77529-00077529-000-03, 77529-000-09, 77529-000-16, 77529-000-67

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
a56a8a9d-04b8-2d26-e053-2995a90ac1eda56a8c80-0d50-bd38-e053-2a95a90a51d62020-05-11WarningsExact identifier
spl id: a56a8a9d-04b8-2d26-e053-2995a90ac1ed
spl set id: a56a8c80-0d50-bd38-e053-2a95a90a51d6

Reported adverse events (FAERS/openFDA)#

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