WELAMD Maximum Strength Antibacterial Hand Sanitizer

Manufacturer
AVP Labs and Investment Group LLC
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:40

Label at a glance#

ProductWELAMD Maximum Strength Antibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Put enough product on hands to cover surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient (by volume)

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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 fire or flame.

Do not use:

OTC - DO NOT USE SECTION

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

When using this product:

OTC - WHEN USING SECTION

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use:

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

Put enough product on hands to cover surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to
avoid swallowing.

Other information:

SPL UNCLASSIFIED SECTION

Store between 15˚-30˚C (59˚-86˚F). Avoid Freezing and excessive heat above 40˚C (104˚F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Carbomer,Glycerine, Triethanolamine, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80595-001-06WELAMD Maximum Strength Antibacterial Hand Sanitizer170 mL in 1 BOTTLEGEL1701
80595-001-08WELAMD Maximum Strength Antibacterial Hand Sanitizer226 mL in 1 BOTTLEGEL2261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80595-001WELAMD MAXIMUM STRENGTH ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [AVP LABS AND INVESTMENT GROUP LLC]1Legacy NDC, 2 package rows20201001_b06311b8-9af7-874b-e053-2995a90a17ec.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
80595-00180595-001-06, 80595-001-08

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
b06311b8-9af8-874b-e053-2995a90a17ecb06311b8-9af7-874b-e053-2995a90a17ec2020-09-28WarningsExact identifier
spl id: b06311b8-9af8-874b-e053-2995a90a17ec
spl set id: b06311b8-9af7-874b-e053-2995a90a17ec

Reported adverse events (FAERS/openFDA)#

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