Simpurity Hand Sanitizer

Manufacturer
Truesdell Manufacturing & Consulting, LLC
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:49

Label at a glance#

ProductSimpurity Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

Helps reduce bacteria on the skin 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 (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Simpurity 75% alcohol Hand Sanitizer

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the 1994 tentative final monograph for consumer antiseptics.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. hydroxyethylcellulose
  3. aloe powder
  4. propylene glycol
  5. hyaluronic acid
  6. tea tree essential oil
  7. vitamin E
  8. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. The product has undergone finished formulation product testing (kill study) to confirm effifacy and safety.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria on the skin 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

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

distilled water
hydroxyethylcellulose
aloe powder
propylene glycol
hyaluronic acid
tea tree essential oil
vitamin E

74069-002-08 240 mL Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

240 mL NDC: 074069-002-08

74069-002-08 image74069-002-08 image

74069-002-04 Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 mL NDC: 074069-002-04

074069-002-04 image074069-002-04 image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN3
1305100ethanol 0.75 ML/ML Topical GelSCD3
1305100ethanol 75 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74069-002-042022-07-29C16284748780-1e4f33bdf-b2b6-d8a0-e053-dadaa90a6e4eSimpurity Hand Sanitizer, 4 oz.
74069-002-082022-07-29C16284748780-1e4f33bdf-b2b6-d8a0-e053-dadaa90a6e4eSimpurity Hand Sanitizer, 4 oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74069-002-04Simpurity Hand Sanitizer120 mL in 1 BOTTLE, GLASSGEL1203
74069-002-08Simpurity Hand Sanitizer240 mL in 1 BOTTLE, GLASSGEL2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74069-002SIMPURITY HAND SANITIZER (ALCOHOL) GEL [TRUESDELL MANUFACTURING & CONSULTING, LLC]3Legacy NDC, 2 package rows20211221_a47cf893-4ec1-6e8d-e053-2a95a90a4cf5.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
74069-00274069-002-08, 74069-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
d397dd80-2ee8-e490-e053-2a95a90a9e83a47cf893-4ec1-6e8d-e053-2a95a90a4cf52021-12-20WarningsExact identifier
spl id: d397dd80-2ee8-e490-e053-2a95a90a9e83
spl set id: a47cf893-4ec1-6e8d-e053-2a95a90a4cf5

Reported adverse events (FAERS/openFDA)#

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