FDA.reportPublic FDA data

Redicare Hand Sanitizer

Manufacturer
Redicare LLC
Effective date
2020-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:35:23

Label at a glance#

ProductRedicare Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

For personal use for hand sanitizing to decrease bacteria on skin.

Dosage and administration

Apply a small amount to palm. Briskly rub, covering hands with product. Allow to dry. Children should always be supervised when using this product.

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

Ethyl Alcohol 80% v/v. Purpose: Antibacterial Agent

Uses

INDICATIONS & USAGE SECTION

For personal use for hand sanitizing to decrease bacteria on skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • internally
  • on face or near eyes - in case of eye contact, flush thoroughly
  • near heat/sparks/open flames
  • on children less than 2 months old.

OTC - ASK DOCTOR SECTION

Ask a doctor if you have redness or irritation that 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

Apply a small amount to palm. Briskly rub, covering hands with product. Allow to dry. Children should always be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 fl oz - 237 mL NDC: 71105-222-02

8oz8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 fl. oz.

2 fl oz2 fl oz

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
71105-22271105-222-02, 71105-222-08

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
HYDROGEN PEROXIDEBBX060AN9VIACT
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
d57cbfba-9626-3bf6-e053-2a95a90abe06a368af39-57a2-3ec0-e053-2995a90ae3612022-01-13WarningsExact identifier
spl set id: a368af39-57a2-3ec0-e053-2995a90ae361

Reported adverse events (FAERS/openFDA)#

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