MedPath

Walgreens

Walgreens Hand Sanitizer-0363-0859

Approved
Approval ID

eff97d19-8f15-5ea7-e053-2995a90aeae4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 1, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0859
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 1, 2025
FDA Product Classification

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-6Inactive
Code: 5655G9Y8AQ
Classification: IACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)Inactive
Code: 2N8MDB79NA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BASIC BLUE 1Inactive
Code: 92N74OA24D
Classification: IACT
FRAGRANCE CLEAN ORC0600327Inactive
Code: 329LCV5BTF
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BASIC YELLOW 5Inactive
Code: 07BP340B4T
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALCOHOLActive
Quantity: 700 mg in 1 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

Principal Display Panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/15/2023

Uses

For personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/15/2023

Active Ingredient

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/15/2023

Purpose

Antiseptic

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/15/2023

Directions

  • For occasional and personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.

WARNINGS SECTION

LOINC: 34071-1Updated: 2/15/2023

Warnings

For external use only.

  • Flammable
  • keep away from source of heat or fire

Do not use

  • on infants less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin.

When using this product avoid

  • contact with eyes.If contact occurs, rinse eyes thorughly with water.
  • Do not inhale.

Stop use and ask a doctor

if irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/15/2023

Inactive Ingredients

Aloe Barbadensis Leaf Juice, AMP-Acrylates/Vinyl Isodecanate Crossploymer, Blue 1 (Cl 42090), Fragrance (Parfum), Glycerin, Isopropyl Alcohol, Isopropyl Myristate, PEG-6.Tocopheryl Acetate, Water (Aqua), Yellow 5 (Cl 19140),

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Walgreens - FDA Drug Approval Details