FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Ripshot Enterprises Corp
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:25:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until 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)

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 (4% v/v).
  3. Hydrogen peroxide (0.1251% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Polyquaternium-10 (1%v/v) for its anti-static and moisturizing properties

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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 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

  • Place enough product on hands to cover all surfaces. Rub hands together until 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP, Polyquaternium-10

Ripshot Hand Sanitizer Formula

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59.1471mL NDC: 78586-435-02 59.1 mL Label59.1 mL Label

OR

2oz Alternative Label2oz Alternative Label

118.294mL NDC: 78586-435-04

118.2mL Label118.2mL Label

OR

4oz Alternate Label4oz Alternate Label

236.588mL NDC: 78586-435-08 236.5mL Label236.5mL Label

473.176mL NDC: 78586-435-16

473.1 mL Label]473.1 mL Label]

OR

16oz Alternative Label16oz Alternative Label

946.353mL NDC: 78586-435-32 946.3 m/L Label946.3 m/L Label

OR

1L Alternative Label1L Alternative Label

3785.41mL NDC: 78586-435-40

128oz Label128oz Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78586-435-022022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer
78586-435-042022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer
78586-435-082022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer
78586-435-162022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer
78586-435-322022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer
78586-435-402022-01-28C16284748780-1d6a99b39-5fd0-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78586-435-02Hand Sanitizer59.1471 mL in 1 BOTTLE, DISPENSINGGEL59.14713
78586-435-04Hand Sanitizer118.294 mL in 1 BOTTLE, DISPENSINGGEL118.2943
78586-435-08Hand Sanitizer236.588 mL in 1 BOTTLE, DISPENSINGGEL236.5883
78586-435-16Hand Sanitizer473.176 mL in 1 BOTTLE, DISPENSINGGEL473.1763
78586-435-32Hand Sanitizer946.353 mL in 1 BOTTLE, DISPENSINGGEL946.3533
78586-435-40Hand Sanitizer3780 mL in 1 BOTTLE, DISPENSINGGEL37803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78586-435HAND SANITIZER (ALCOHOL) GEL [RIPSHOT ENTERPRISES CORP]3Legacy NDC, 6 package rows20200819_a8c50f59-d3bc-008d-e053-2a95a90ac217.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78586-43578586-435-02, 78586-435-04, 78586-435-08, 78586-435-16, 78586-435-32, 78586-435-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYQUATERNIUM-10 (125 MPA.S AT 2%)L45WU8S981IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
ad29db66-f589-dc4f-e053-2a95a90aae6ea8c50f59-d3bc-008d-e053-2a95a90ac2172020-08-18WarningsExact identifier
spl id: ad29db66-f589-dc4f-e053-2a95a90aae6e
spl set id: a8c50f59-d3bc-008d-e053-2a95a90ac217

Reported adverse events (FAERS/openFDA)#

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