OTC Medication Information: S and B Farmstead Hand Sanitizer

S AND B FARMSTEAD HAND SANITIZER- alcohol liquid
S&B Farmstead Distillery

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

active
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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.

Uses
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Warnings

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

Warnings
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Do not use

do not use
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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 using
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

stop use
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Keep out of reach of children. If swallowed, get medical help o r contact a Poison Control Center right away.

keep out
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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 swallo wing.
    Directions
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Directions

Other information

Other Information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

inactive
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Keep out

Package Label — Principal Display Panel

000 mL NDC: 00000-000-00

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S AND B FARMSTEAD HAND SANITIZER
s and b farmstead distillery hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74329-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 15141.68 mL in 18927.1 mL
Inactive Ingredients
Ingredient Name Strength
WATER 2091.06 mL in 18927.1 mL
GLYCEROL FORMAL 346.22 mL in 18927.1 mL
HYDROGEN PEROXIDE 875.43 mL in 18927.1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74329-0001-3 18927.1 mL in 1 PAIL None
2 NDC:74329-0001-2 473.18 mL in 1 BOTTLE, PLASTIC None
3 NDC:74329-0001-4 59.15 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 03/31/2020
Labeler — S&B Farmstead Distillery (075464660)
Establishment
Name Address ID/FEI Operations
S&B Farmstead Distillery 075464660 manufacture (74329-0001)

Revised: 03/2020 S&B Farmstead Distillery

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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