FDA.reportPublic FDA data

Purity Gel 70% Alcohol

Manufacturer
Alta Pureza, Maquiladora, S.A. de C.V.
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:19:03

Label at a glance#

ProductHand Sanitizer
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(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

  • 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

Water (aqua), carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600 mL NDC: 77905-001-01

Purity Gel 600 mLPurity Gel 600 mL

1000 mL NDC: 77905-001-02

Purity Gel 1LPurity Gel 1L

4000 mL NDC: 77905-001-03

Purity Gel 4LPurity Gel 4L

3875 mL NDC: 77905-001-04

Purity Gel 1 GalPurity Gel 1 Gal

500 mL NDC: 77905-001-05

Purity Gel 500 mLPurity Gel 500 mL

250 mL NDC: 77905-001-06

Purity Gel 250 mLPurity Gel 250 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77905-001-012022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol
77905-001-022022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol
77905-001-032022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol
77905-001-042022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol
77905-001-052022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol
77905-001-062022-01-28C16284748780-1d6a99b39-f6b2-a426-e053-dadaa90af4c2Purity Gel 70% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77905-001-01Hand Sanitizer600 mL in 1 BOTTLEGEL6004
77905-001-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10004
77905-001-03Hand Sanitizer4000 mL in 1 BOTTLEGEL40004
77905-001-04Hand Sanitizer3875 mL in 1 BOTTLEGEL38754
77905-001-05Hand Sanitizer500 mL in 1 BOTTLEGEL5004
77905-001-06Hand Sanitizer250 mL in 1 BOTTLEGEL2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77905-001HAND SANITIZER (ALCOHOL) GEL [ALTA PUREZA, MAQUILADORA, S.A. DE C.V.]4Legacy NDC, 6 package rows20200626_a6094da4-29e8-6a58-e053-2a95a90a7394.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77905-00177905-001-01, 77905-001-02, 77905-001-03, 77905-001-04, 77905-001-05, 77905-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a8f2001f-f5ef-467a-e053-2a95a90a2512a6094da4-29e8-6a58-e053-2a95a90a73942020-06-25WarningsExact identifier
spl id: a8f2001f-f5ef-467a-e053-2a95a90a2512
spl set id: a6094da4-29e8-6a58-e053-2a95a90a7394

Reported adverse events (FAERS/openFDA)#

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