Seven Three Hand Sanitizer

Manufacturer
Seven Three Distilling Company, LLC
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 23:38:00

Label at a glance#

ProductSeven Three Hand Sanitizer
Active ingredientHYDROGEN PEROXIDE, ALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For childres under 6, use only under adult supervision Not recommended for infants

Storage and handling

Do not store above 105°F May discolor some fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Methacrylic Acid - Ethyl Acrylate Copolymer (5.5% v/v)

The firm does 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

Ethanol 70%. Purpose: Antiseptic

Hydrogen Peroxide <1%. Purpose: Antiseptic

73_Gel73_Gel

Use

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only - hands.

Flammable. Keep away from heat or flame.

When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

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

Warnings

OTC - DO NOT USE SECTION

  • for children under 6, use only under adult supervision
  • not recommended for infants
  • avoid contact with broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush thoroghly with water.

Avoid contact with broken skin.

Do not ingest or inhale.

Stop use and ask a doctor if skin irritation develops.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops.

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.
  • For childres under 6, use only under adult supervision
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105°F
  • May discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbopol, lemongrass oil

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

128 FL OZ (3785ML) 75219-7300-1

73_gel73_gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75219-7300-12022-07-29C16284748780-1e4f33bdf-aa4f-d8a0-e053-dadaa90a6e4ea342115c-36ce-0e7e-e053-2995a90a35c5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75219-7300-1Seven Three Hand Sanitizer3785 mL in 1 BOTTLEGEL378515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75219-7300SEVEN THREE HAND SANITIZER (ALCOHOL ANTISEPTIC 70%) GEL [SEVEN THREE DISTILLING COMPANY, LLC]15Legacy NDC, 1 package rows20210211_a342115c-36ce-0e7e-e053-2995a90a35c5.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75219-730075219-7300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
baee9733-a790-6891-e053-2a95a90ab80ca342115c-36ce-0e7e-e053-2995a90a35c52021-02-09WarningsExact identifier
spl id: baee9733-a790-6891-e053-2a95a90ab80c
spl set id: a342115c-36ce-0e7e-e053-2995a90a35c5

Reported adverse events (FAERS/openFDA)#

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