CAJUN SPIRITS HAND SANITIZER- ethanol 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.

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Active Ingredients[s].

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 32ozFront Label 32ozFront Label 6ozFront Label 1ozBack Label - All versionsFront Label 1/2galFront Label 2ozFront Label 5galFront Label 16oz4oz Front

CAJUN SPIRITS HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74152-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL23.659 mL  in 29.574 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.037 mL  in 29.574 mL
WATER (UNII: 059QF0KO0R) 5.449 mL  in 29.574 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E) 0.429 mL  in 29.574 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74152-001-0129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
2NDC:74152-001-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
3NDC:74152-001-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
4NDC:74152-001-06177.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
5NDC:74152-001-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
6NDC:74152-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
7NDC:74152-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
8NDC:74152-001-0518927 mL in 1 PAIL; Type 0: Not a Combination Product03/27/2020
9NDC:74152-001-181893 mL in 1 JUG; Type 0: Not a Combination Product03/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/27/2020
Labeler - Cajun Spirits Distillery, LLC (002075890)
Establishment
NameAddressID/FEIBusiness Operations
Cajun Spirits Distillery, LLC002075890manufacture(74152-001)

Revised: 3/2020
Document Id: a1d3371e-ee6d-5304-e053-2995a90a2e7d
Set id: a1d3371e-ee6c-5304-e053-2995a90a2e7d
Version: 1
Effective Time: 20200327
 
Cajun Spirits Distillery, LLC