FDA Label for Crooked Creek Distillery Inc Hand Sanitizer
View Indications, Usage & Precautions
Crooked Creek Distillery Inc Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Crooked Creek Distillery Inc. 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.
Front Label50ml
CROOKED CREEK DSITLLERY
HAND SANITIZER
Alcohol Antiseptic 80% - Topical Solution
Hand Sanitizer - Non-sterile Solution - [50mL]
Produced to World Health Organization (WHO) formulas and to production and labeling requirements as established and approved by the Federal Drug Administration (FDA)
FDA Label ID – 74072
DUNS 096927542
Back Label50ml
Drug Facts
Active ingredient[s] Purpose
Alcohol 80% v/v.….......................................................................................................................Antiseptic
Use[s]
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.
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
FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Batch ID: Date Produced:
Purpose
Purpose
Antiseptic
Active Ingredients
Active ingredient[s]
Alcohol 80% v/v
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
Do not use
in children less than 2 months of age
on open skin wounds
Stop Use And Ask A Doctor
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.
Inactive Ingredients
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
Questions And Concerns
FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Batch Tracking And Production Date
Batch ID:
Date Produced:
Usage
Use[s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available
When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Indications And Usage
Use[s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Directions
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.
Storage
Other information
Store between 15- 30C (59- 86F)
Avoid freezing and excessive heat above 40C (104F)
Dosage And Administration
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)
* Please review the disclaimer below.