EC Pure Instant Cream Hand Sanitizer Zen

Manufacturer
Ec Labs Inc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:00

Label at a glance#

ProductEC Pure Instant Cream Hand Sanitizer Zen
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Apply a small amount to hands and spread evenly. Rub thoroughly into hands for at lease 30 secconds. Allow to dry. For occasional and personal use. Superrvise children under 6 years of age when using this product.

Storage and handling

Store between 59-86F Avoid freezing and excessive heat above104F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 63% w/w. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Eliminates bacteria and germs.

Warnings

WARNINGS SECTION

Flammable. Keep away from open flame and sources of heat. This product is intended for external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use iin children less than 2 months of age and on open wounds.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use if irritation or redness develops and consult a doctor.

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

Apply a small amount to hands and spread evenly.

Rub thoroughly into hands for at lease 30 secconds.

Allow to dry.

For occasional and personal use.

Superrvise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 59-86F
  • Avoid freezing and excessive heat above104F

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zen labelzen label60g NDC:76555-005-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76555-005-012024-01-30C16284748780-11030e365-1721-111a-e063-dadaa90a10e2Eveline Charles Pure Instant Cream Hand Sanitizer Zen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76555-005-01EC Pure Instant Cream Hand Sanitizer Zen60 g in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76555-005EC PURE INSTANT CREAM HAND SANITIZER ZEN (ALCOHOL) CREAM [EC LABS INC]2Legacy NDC, 1 package rows20220115_ac142ee5-8225-199c-e053-2995a90ab9bf.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76555-00576555-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
d58d6bd8-513d-7f11-e053-2a95a90a7eceac142ee5-8225-199c-e053-2995a90ab9bf2022-01-14WarningsExact identifier
spl id: d58d6bd8-513d-7f11-e053-2a95a90a7ece
spl set id: ac142ee5-8225-199c-e053-2995a90ab9bf

Reported adverse events (FAERS/openFDA)#

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