Hand Sanitizer

Manufacturer
Rebel Rebel Personal Care Corp.
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:16

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).

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 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 65%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Antiseptic (skin) cleanser to help reduce bacteria on skin.

Warnings

WARNINGS SECTION

Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.

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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).

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

Non Active Ingredients: Purified Water, Aloe Barbadensis Extract, Glycerin, Polysorbate 20, Denatonium Benzoate, Fragrance.

RECENT MAJOR CHANGES SECTION

Changes to:

  1. Recommended Use: Antiseptic (skin) cleanser to help reduce bacteria on skin.
  2. Direction: Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).
  3. Warnings: Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 82092-001-01

60 ml French Lavender NDC 82092 001 0160 ml French Lavender NDC 82092 001 0160 ml French Lavender NDC 82092 001 0160 ml French Lavender NDC 82092 001 0160 mL NDC: 82092-002-01

60 ml Magnolia NDC 82092 002 0160 ml Magnolia NDC 82092 002 01

60 ml Magnolia NDC 82092 002 0160 ml Magnolia NDC 82092 002 01

60 mL NDC: 82092-003-01

60 ml Hawaiian Plumeria NDC 82092 003 0160 ml Hawaiian Plumeria NDC 82092 003 0160 ml Hawaiian Plumeria NDC 82092 003 0160 ml Hawaiian Plumeria NDC 82092 003 01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902515ethanol 65 % Topical SprayPSN2
902515ethanol 0.65 ML/ML Topical SpraySCD2
902515ethanol 65 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82092-001-01Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID602
82092-002-01Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID602
82092-003-01Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82092-001HAND SANITIZER (ALCOHOL) LIQUID [REBEL REBEL PERSONAL CARE CORP.]2Legacy NDC, 1 package rows20230117_d16fc3da-5d5e-48f3-e053-2995a90a53d7.zip
82092-002HAND SANITIZER (ALCOHOL) LIQUID [REBEL REBEL PERSONAL CARE CORP.]2Legacy NDC, 1 package rows20230117_d16fc3da-5d5e-48f3-e053-2995a90a53d7.zip
82092-003HAND SANITIZER (ALCOHOL) LIQUID [REBEL REBEL PERSONAL CARE CORP.]2Legacy NDC, 1 package rows20230117_d16fc3da-5d5e-48f3-e053-2995a90a53d7.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82092-00182092-001-01
82092-00282092-002-01
82092-00382092-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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
f26b449a-8c15-44a1-e053-2a95a90a54aed16fc3da-5d5e-48f3-e053-2995a90a53d72023-01-16WarningsExact identifier
spl id: f26b449a-8c15-44a1-e053-2a95a90a54ae
spl set id: d16fc3da-5d5e-48f3-e053-2995a90a53d7

Reported adverse events (FAERS/openFDA)#

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