Hammer Spring Hand Sanitizer: Package Insert and Label Information

HAMMER SPRING HAND SANITIZER- alcohol liquid
Hammer Spring Distillers

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

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

  • 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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Active Ingredients & back label

Drug facts

Active ingredient Purpose

Alcohol 80% v/v…….Antiseptic, Hand Sanitizer

Use(s)

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

Do not use

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

When using

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

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

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

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.

Other information

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

Inactive ingredients

glycerine, hydrogen peroxide, purified water USP

1 Gal / 3.785 L NDC 76837-0001-1

Active Ingredient Section
(click image for full-size original)

Package Label — Principal Display Panel

HAND SANITIZER

ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION

WHO Recommended Hand Rub
Formulation #1

FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
NON-STERILE SOLUTION
NET WT. 1 GALLON / 3.78 L
HAMMER SPRING DISTILLERS
3697 WEST 1987 SOUTH
SALT LAKE CITY, UT. 84104
MADE IN USA

BATCH: _______ DATE: _______

Principal Display Panel
(click image for full-size original)
HAMMER SPRING HAND SANITIZER
hammer spring hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76837-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 98.3 mL in 118 mL
Inactive Ingredients
Ingredient Name Strength
HYDROGEN PEROXIDE 4.9 mL in 118 mL
GLYCEROL FORMAL 1.7 mL in 118 mL
WATER 13 mL in 118 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76837-001-01 3785 mL in 1 BOTTLE, PLASTIC None
2 NDC:76837-001-02 118 mL in 1 BOTTLE, PLASTIC None
3 NDC:76837-001-03 1890 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 04/27/2020
Labeler — Hammer Spring Distillers (106077989)
Registrant — Hammer Spring Distillers (106077989)
Establishment
Name Address ID/FEI Operations
Hammer Spring Distillers 106077989 manufacture (76837-001)

Revised: 05/2020 Hammer Spring Distillers

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