SnoSan Hand Sanitizer: Package Insert and Label Information

SNOSAN HAND SANITIZER- alcohol liquid
J AND L DISTILLING COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

​Alcohol 80% v/v. Purpose: Antiseptic

SnoSan Drug FactsSnoSan Drug Facts

Purpose

Antiseptic, Hand Sanitizer

Drug Facts PurposeDrug Facts Purpose

Use

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

UseUse

Warnings

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

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

Do not use

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

Do Not UseDo Not Use

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.

When usingWhen using

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop useStop use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Out of reachOut of reach

Directions

  • 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.

DirectionsDirections

Other information

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

StorageStorage

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Inactive IngredientsInactive Ingredients

Package Label — Principal Display Panel

NDC: 74283-0001-6

[SnoSan Logo]

Alcohol Antiseptic 80%

WHO Recommended Hand Rub Formula

Hand Sanitizer

Topical Solution

Non-sterile Solution

NET WT: 1 Gallon (3.785L)

J AND L DISTILLING COMPANY [logo]

4843 PEARL ST

BOULDER, CO 80301

CONTACT US: SnoSan@jldistilling.com

Front LabelFront Label
SNOSAN HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74283-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74283-0001-1 700 mL in 1 BOTTLE, PLASTIC None
2 NDC:74283-0001-2 500 mL in 1 BOTTLE, PLASTIC None
3 NDC:74283-0001-3 473 mL in 1 BOTTLE, PLASTIC None
4 NDC:74283-0001-4 118 mL in 1 BOTTLE, PLASTIC None
5 NDC:74283-0001-5 59 mL in 1 BOTTLE, PLASTIC None
6 NDC:74283-0001-6 3785 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/28/2020
Labeler — J AND L DISTILLING COMPANY (062842512)
Establishment
Name Address ID/FEI Operations
J AND L DISTILLING COMPANY 062842512 manufacture (74283-0001)

Revised: 03/2020 J AND L DISTILLING COMPANY

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