FDA.reportPublic FDA data

EC Pure Instant Cream Hand Sanitizer Unscented

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 Unscented
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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

Storage and handling

Store between 59-86F Avoid freezing and excessive heat above 104F

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

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 on 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 eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use if irritation or redness occurs 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 least 30 seconds.

Allow to dry.

For occasional and personal use.

Supervise 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 above 104F

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Purpose

OTC - PURPOSE SECTION

Antimicrobial. Hand sanitizer.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unscented LabelUnscented Label60g NDC: 76555-006-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76555-006-012024-01-30C16284748780-11030e365-1a10-111a-e063-dadaa90a10e2Eveline Charles Pure Instant Cream Hand Sanitizer Unscented

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76555-006-01EC Pure Instant Cream Hand Sanitizer Unscented60 g in 1 TUBECREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76555-006EC PURE INSTANT CREAM HAND SANITIZER UNSCENTED (ALCOHOL) CREAM [EC LABS INC.]2Legacy NDC, 1 package rows20220115_ac15d72d-7d5b-4046-e053-2a95a90ada2a.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
76555-00676555-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PEG/PPG-18/12 DIMETHICONE2AY8NFX9E4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
CYCLOMETHICONENMQ347994ZIACT
SODIUM ACRYLOYLDIMETHYLTAURATE2T9Q6EKI0GIACT

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
d58d782a-d7ba-4749-e053-2a95a90a9f89ac15d72d-7d5b-4046-e053-2a95a90ada2a2022-01-14WarningsExact identifier
spl id: d58d782a-d7ba-4749-e053-2a95a90a9f89
spl set id: ac15d72d-7d5b-4046-e053-2a95a90ada2a

Reported adverse events (FAERS/openFDA)#

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