FDA.reportPublic FDA data

2 in 1 Hand Sanitizer/Disinfectant

Manufacturer
Rocky Research
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:07

Label at a glance#

Product2 in 1 Hand Sanitizer/Disinfectant
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Hands: Spray product in your palm. Rub hands together until dry. Surface: Spray product 6-8 inches from surface until thoroughly wet. Wait about 10 seconds then wipe dry. Do not air dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May cause surface paint or fabric discoloration

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.5% v/v).
  3. Hydrogen peroxide (0.126% v/v).
  4. Distilled water.
  5. Aloe.
  6. Essential oil.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer & Surface Disinfectant

Use

INDICATIONS & USAGE SECTION

Hand Sanitize and surface disinfectantr 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 or flame

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

  • Hands: Spray product in your palm. Rub hands together until dry.
  • Surface: Spray product 6-8 inches from surface until thoroughly wet. Wait about 10 seconds then wipe dry. Do not air dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May cause surface paint or fabric discoloration

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, distilled water, aloe, essential oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2in1 473ml label2in1 473ml label473 ml NDC: 77509-070-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2
808520isopropyl alcohol 70 % Topical SolutionSY2

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
77509-070-012022-01-28C16284748780-1d6a99b39-3e3f-a426-e053-dadaa90af4c22 in1 Hand Sanitizer/Disinfectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77509-070-012 in 1 Hand Sanitizer/Disinfectant473 mL in 1 BOTTLE, SPRAYLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77509-0702 IN 1 HAND SANITIZER/DISINFECTANT (ISOPROPYL ALCOHOL) LIQUID [ROCKY RESEARCH]2Legacy NDC, 1 package rows20200529_a58fe22b-45c8-3032-e053-2995a90a6f4a.zip

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
77509-07077509-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a6b8617b-7401-5287-e053-2995a90aabfaa58fe22b-45c8-3032-e053-2995a90a6f4a2020-05-28WarningsExact identifier
spl id: a6b8617b-7401-5287-e053-2995a90aabfa
spl set id: a58fe22b-45c8-3032-e053-2995a90a6f4a

Reported adverse events (FAERS/openFDA)#

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