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:

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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.
Sage.
Osha root.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age
on open skin wounds

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.

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.

Directions

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.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, sage, osha root

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 - Gallon

2.84 L - Front Label

2.84 L - Back Label

1 L - Front Label

1 L - Back Label

.18 L - 6oz Bottle

.95 L - 32 oz Bottle

.06 L - 2oz Bottle

ROLLING STILL HAND AND SURFACE SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76581-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L in 1 L

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.015 L in 1 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.00125 L in 1 L
WATER (UNII: 059QF0KO0R)
LIGUSTICUM PORTERI ROOT (UNII: 81FGO4H42J)
SAGE (UNII: 065C5D077J)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76581-002-02	0.06 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/15/2020
2	NDC:76581-002-03	1 L in 1 POUCH; Type 0: Not a Combination Product	04/15/2020
3	NDC:76581-002-04	0.95 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/25/2020
4	NDC:76581-002-06	2.84 L in 1 POUCH; Type 0: Not a Combination Product	05/25/2020
5	NDC:76581-002-01	3.79 L in 1 JUG; Type 0: Not a Combination Product	05/07/2020
6	NDC:76581-002-07	0.177 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2020

Labeler - Rolling Still Wellness, LLC (117500092)

Name	Address	ID/FEI	Business Operations
Establishment
Rolling Still Wellness, LLC		117500092	manufacture(76581-002)