Premium Hand Sanitizer Gel

Manufacturer
SOOTSOAP SUPPLY CO LTD | Natures Formulae Health Products Ltd.
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:58

Label at a glance#

ProductPremium Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure8 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.

Label contents#

Full prescribing information#

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Aloe Barbadensis Leaf Juice Powder, Hydroxyethyl cellulose, Mentha Piperita (Peppermint) Essential Oil

Uses

INDICATIONS & USAGE SECTION

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

For use when soap and water are not available.

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.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol (Ethanol) 70% v/v

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. Do not use in 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81524-111-01Premium Hand Sanitizer Gel5 mL in 1 BOTTLEGEL53
81524-111-04Premium Hand Sanitizer Gel60 mL in 1 BOTTLEGEL603
81524-111-07Premium Hand Sanitizer Gel473 mL in 1 BOTTLEGEL4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81524-111PREMIUM HAND SANITIZER GEL (ALCOHOL) GEL [SOOTSOAP SUPPLY CO LTD]3Legacy NDC, 3 package rows20240127_bb144885-fad6-3699-e053-2995a90aa51d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81524-11181524-111-01, 81524-111-04, 81524-111-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
0fdd8553-ec6b-aeba-e063-6394a90a8603bb144885-fad6-3699-e053-2995a90aa51d2024-01-26WarningsExact identifier
spl id: 0fdd8553-ec6b-aeba-e063-6394a90a8603
spl set id: bb144885-fad6-3699-e053-2995a90aa51d

Reported adverse events (FAERS/openFDA)#

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