OTC Medication Information: Cajun Spirits Hand Sanitizer

CAJUN SPIRITS HAND SANITIZER- alcohol liquid
Cajun Spirits Distillery, LLC

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.

Alcohol 80%v/

Purpose

Anticeptic

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.

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

Hand Sanitizer Labels

Front Label 32oz
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Front Label 32oz
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Front Label 6oz
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Front Label 1oz
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Back Label -- All versions
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Front Label 1/2gal
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Front Label 2oz
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Front Label 5gal
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Front Label 16oz
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4oz Front
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CAJUN SPIRITS HAND SANITIZER
ethanol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74152-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 23.659 mL in 29.574 mL
Inactive Ingredients
Ingredient Name Strength
HYDROGEN PEROXIDE 0.037 mL in 29.574 mL
WATER 5.449 mL in 29.574 mL
GLYCEROL FORMAL 0.429 mL in 29.574 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74152-001-01 29.6 mL in 1 BOTTLE, PLASTIC None
2 NDC:74152-001-02 59.1 mL in 1 BOTTLE, PLASTIC None
3 NDC:74152-001-04 118.3 mL in 1 BOTTLE, PLASTIC None
4 NDC:74152-001-06 177.4 mL in 1 BOTTLE, PLASTIC None
5 NDC:74152-001-08 236.6 mL in 1 BOTTLE, PLASTIC None
6 NDC:74152-001-16 473 mL in 1 BOTTLE, PLASTIC None
7 NDC:74152-001-32 946 mL in 1 BOTTLE, PLASTIC None
8 NDC:74152-001-05 18927 mL in 1 PAIL None
9 NDC:74152-001-18 1893 mL in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/27/2020
Labeler — Cajun Spirits Distillery, LLC (002075890)
Establishment
Name Address ID/FEI Operations
Cajun Spirits Distillery, LLC 002075890 manufacture (74152-001)

Revised: 03/2020 Cajun Spirits Distillery, LLC

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.

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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