FDA.reportPublic FDA data

Rolling Still Hand and Surface Sanitizer

Manufacturer
Rolling Still Wellness, LLC
Effective date
2020-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:45

Label at a glance#

ProductRolling Still Hand and Surface Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Spray directly onto hands, rub together and allow to air dry. No rinsing needed. Supervise children under 6 years of age when using this product. Spray directly onto hands, rub together and allow to air dry. No rinsing necessary. Supervise children under the age of 6 when using this product. 06/01/2020

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) (70%, 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.
  5. Sage.
  6. Osha root.

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

Spray directly onto hands, rub together and allow to air dry. No rinsing needed. Supervise children under 6 years of age when using this product.

RECENT MAJOR CHANGES SECTION

Spray directly onto hands, rub together and allow to air dry. No rinsing necessary. Supervise children under the age of 6 when using this product.

06/01/2020

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, sage, osha root

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.79 L NDC: 76581-001-01

2.84 L NDC: 76581-001-06

.95 L NDC: 76581-001-04

1 L NDC: 76581-001-03

.06 L NDC: 76581-001-02

0.177L NDC: 76581-002-07

3.79 L - Gallon3.79 L - Gallon

2.84 L - Front Label2.84 L - Front Label

2.84 L - Back Label2.84 L - Back Label

1 L - Front Label1 L - Front Label

1 L - Back Label1 L - Back Label

.18 L - 6oz Bottle.18 L - 6oz Bottle

.95 L - 32 oz Bottle.95 L - 32 oz Bottle

.06 L - 2oz Bottle.06 L - 2oz Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl 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
76581-002-012022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer
76581-002-022022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer
76581-002-032022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer
76581-002-042022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer
76581-002-062022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer
76581-002-072022-01-28C16284748780-1d6a99b39-9aaa-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76581-002-01Rolling Still Hand and Surface Sanitizer3.79 L in 1 JUGLIQUID3.792
76581-002-02Rolling Still Hand and Surface Sanitizer0.06 L in 1 BOTTLE, SPRAYLIQUID0.062
76581-002-03Rolling Still Hand and Surface Sanitizer1 L in 1 POUCHLIQUID12
76581-002-04Rolling Still Hand and Surface Sanitizer0.95 L in 1 BOTTLE, SPRAYLIQUID0.952
76581-002-06Rolling Still Hand and Surface Sanitizer2.84 L in 1 POUCHLIQUID2.842
76581-002-07Rolling Still Hand and Surface Sanitizer0.177 L in 1 BOTTLE, SPRAYLIQUID0.1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76581-002ROLLING STILL HAND AND SURFACE SANITIZER (ALCOHOL) LIQUID [ROLLING STILL WELLNESS, LLC]2Legacy NDC, 6 package rows20201224_a4f1ca02-66a7-4d65-e053-2995a90ae890.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
76581-00276581-002-02, 76581-002-03, 76581-002-04, 76581-002-06, 76581-002-01, 76581-002-07

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LIGUSTICUM PORTERI ROOT81FGO4H42JIACT
SAGE065C5D077JIACT

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
b33a8f50-061d-3138-e053-2995a90a81d2a4f1ca02-66a7-4d65-e053-2995a90ae8902020-11-03WarningsExact identifier
spl id: b33a8f50-061d-3138-e053-2995a90a81d2
spl set id: a4f1ca02-66a7-4d65-e053-2995a90ae890

Reported adverse events (FAERS/openFDA)#

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