Label: CROOKED CREEK DISTILLERY INC HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74072-100-07 - Packager: Crooked Creek Distillery Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 25, 2020
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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
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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 woundsWhen 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:
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.
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:
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.
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) -
INGREDIENTS AND APPEARANCE
CROOKED CREEK DISTILLERY INC HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74072-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4.17 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74072-100-07 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/25/2020 Labeler - Crooked Creek Distillery Inc (096927542) Registrant - Crooked Creek Distillery Inc (096927542) Establishment Name Address ID/FEI Business Operations Crooked Creek Distillery Inc 096927542 manufacture(74072-100)