Hand Sanitizer

Manufacturer
Pearmine Health Ltd
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:24:11

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wipe hands thoroughly including between fingers & around fingernails. Allow to air dry. Dispose of after use.

Storage and handling

Store between 15°-25°C (59-77°F). Avoid excessive heat and direct sunlight. Once opened keep pack sealed.

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) (80%, 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.

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 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic.

Use

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 heat, flame, sparks, electricals. Do no smoke, drink or inhale.

Do not use

OTC - DO NOT USE SECTION

Do not use as baby wipes, or on children under 2 years old. On broken skin. Around the eyes - in case of eye contact, rinse eyes thoroughly with water. If irritation persists, seek medical advice.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and consult a doctor if irritation or rash occurs. Keep out of reach of children.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Wipe hands thoroughly including between fingers & around fingernails. Allow to air dry. Dispose of after use.

Other information

STORAGE AND HANDLING SECTION

Store between 15°-25°C (59-77°F). Avoid excessive heat and direct sunlight. Once opened keep pack sealed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, glycerin, Citrus Limon Peel Oil.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 alcohol wipes packet label25 alcohol wipes packet label25 wipes NDC: 79179-0738-1

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
79179-073879179-0738-1

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
GLYCERINPDC6A3C0OXIACT
LEMON OILI9GRO824LLIACT
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
1b2cc64e-c2ef-553b-e063-6294a90a4840a849491a-d1f5-78f4-e053-2995a90af3892024-06-18WarningsExact identifier
spl set id: a849491a-d1f5-78f4-e053-2995a90af389

Reported adverse events (FAERS/openFDA)#

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