Health and Wellness Essentials Hand Sanitizer

Manufacturer
Health & Wellness Essentials Inc.
Effective date
2020-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:40

Label at a glance#

ProductHealth and Wellness Essentials Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand sanitizer to decrease bacteria on skin Recommended for repeated use

Dosage and administration

Squeeze appropriate amount of sanitizer on to hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to decrease bacteria on skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

When using this product 

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

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.

Other Information:

SPL UNCLASSIFIED SECTION

Store below 110F (43C).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze appropriate amount of sanitizer on to hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Tetrahydroxypropyl Ethylenediamine

Package Labeling: 250 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 500 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78841-000-082022-01-28C16284748780-1d6a99b39-dd00-a426-e053-dadaa90af4c2Health & Wellness Essentials Hand Sanitizer
78841-000-162022-01-28C16284748780-1d6a99b39-dd00-a426-e053-dadaa90af4c2Health & Wellness Essentials Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78841-000-08Health and Wellness Essentials Hand Sanitizer250 mL in 1 BOTTLE, PUMPGEL2501
78841-000-16Health and Wellness Essentials Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78841-000HEALTH AND WELLNESS ESSENTIALS HAND SANITIZER (ALCOHOL) GEL [HEALTH & WELLNESS ESSENTIALS INC.]1Legacy NDC, 2 package rows20200701_a93b55c2-74b4-e4b3-e053-2995a90abce1.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
78841-00078841-000-08, 78841-000-16

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
a93b3f50-b345-b573-e053-2995a90a7b2ca93b55c2-74b4-e4b3-e053-2995a90abce12020-06-29WarningsExact identifier
spl id: a93b3f50-b345-b573-e053-2995a90a7b2c
spl set id: a93b55c2-74b4-e4b3-e053-2995a90abce1

Reported adverse events (FAERS/openFDA)#

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