BIG SPRING SPIRITS HAND SANITIZER- big spring spirits hand sanitizer liquid 
Nittany Valley Distilling, LLC

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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

back

Purpose

Antiseptic, Hand Sanitizer

backlabel

Use

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

back1

Do not use

back4

Warnings

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

back2

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.

back5

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

back6

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

back7

Directions

back8

Other information

back9

Inactive ingredients

glycerin, hydrogen peroxide, purified water

back10

Package Label - Principal Display Panel

237 mL NDC: 74358-001-1

front

BIG SPRING SPIRITS HAND SANITIZER 
big spring spirits hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74358-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL189.6 mL  in 237 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 3.4 mL  in 237 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.3 mL  in 237 mL
WATER (UNII: 059QF0KO0R) 43.7 mL  in 237 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74358-0001-1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/25/2020
Labeler - Nittany Valley Distilling, LLC (085896519)
Registrant - Nittany Valley Distilling, LLC (085896519)
Establishment
NameAddressID/FEIBusiness Operations
Nittany Valley Distilling, LLC085896519manufacture(74358-0001)

Revised: 3/2020
Document Id: a22d4e42-0dbe-3c61-e053-2a95a90af781
Set id: a22d6354-cf0c-0d47-e053-2a95a90aa266
Version: 1
Effective Time: 20200331
 
Nittany Valley Distilling, LLC