Hand Sanitizer

Manufacturer
Valor Fractal, LLC
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:23:00

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions: apply a small amount in your hands and rub until it dries, for children under 6, use only under adult supervision.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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. Carbomer 940 (0.40% v/v)
  3. Trolamine (0.55% v/v).
  4. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin that could cause diseases.

Warnings

WARNINGS SECTION

For external use only. Flammable product. Keep out of reach of children. Keep at a temperature not higher than 105F. May discolor some fabrics, harmful to wood finishes.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product: Keep out of eyes. In case of contact, flush thoroughly with water. Do not inhale or ingest.

Stop using and ask a doctor: if irritation and redness develop and presists for more than 24 hours.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop using and ask a doctor: if irritation or redness develop and persists for more than 24 hours.

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

Directions: apply a small amount in your hands and rub until it dries, for children under 6, use only under adult supervision.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP, Trolamine, Carbomer 940, and other stabilizers.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

251 mL NDC: 79047-001-01

valorvalor

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79047-00179047-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b7cae347-4426-88ff-e053-2995a90ab743a9c02dd1-5ffd-2129-e053-2995a90a34dd2020-12-31WarningsExact identifier
spl set id: a9c02dd1-5ffd-2129-e053-2995a90a34dd

Reported adverse events (FAERS/openFDA)#

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