FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
ECOTOMORROW LLC | AZS INDUSTRIA E COMERCIO EIRELI
Effective date
2022-05-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:01:53

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product. Use only as directed.

Storage and handling

Store at room temperature 68-77F May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the OTC Monograph not final part 333E.

The hand sanitizer is manufactured using the following ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)).
  2. Glycerol (1.60% v/v).
  3. Cymbopogon Flexuosos Leaf Oil.
  4. Menthol.
  5. Methna Arvensis Leaf Oil.
  6. Aqua (purified 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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

  • For washing hands to decrease bacteria on skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes.
  • if contact occurs, flush thoroughly with water.
  • avoid contact with broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if redness or irritation appears and lasts

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

  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children in the use of this product.
  • Use only as directed.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 68-77F
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua (purified water), glycerin, cymbopogon flexuosus leaf oil, menthol, mentha arvencis leaf oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label completePackage Label complete

Package Label PDP on spray bottlePackage Label PDP on spray bottle

120mL NDC: 77770-002-01

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77770-00277770-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CYMBOPOGON FLEXUOSUS LEAF7LJ4Y1UJG7IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT

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
de39de25-ca7d-3a86-e053-2a95a90a631aa850804d-7673-471e-e053-2995a90a321e2022-05-04WarningsExact identifier
spl id: de39de25-ca7d-3a86-e053-2a95a90a631a
spl set id: a850804d-7673-471e-e053-2995a90a321e

Reported adverse events (FAERS/openFDA)#

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