FDA Label for Hammer Spring Hand Sanitizer
View Indications, Usage & Precautions
Hammer Spring Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Hammer Spring Distillers. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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) (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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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
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
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: _______
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