Willies Cool Citrus Scent Hand Sanitizer by Willies Distillery

Willies Cool Citrus Scent Hand Sanitizer by

Drug Labeling and Warnings

Willies Cool Citrus Scent Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Willies Distillery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WILLIES COOL CITRUS SCENT HAND SANITIZER- alcohol liquid 
Willies Distillery

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 Ingredient

Alcohol 70% 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. Product is Flammable. Keep away from Heat and Flame

Do not Use

• On Children less than 2 months 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 Posion Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These ma 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.

• Place enough product on hands to cover all surfaces, Rub hands together until dry.
• Avoid freexing and excessive heat above 40C (104F)
• Flamable: Keep away from Flame / Fire

Inactive Ingredients

Fragrance, Glycerin, Hydrogen Peroxide, Purified Water (USP)

Package Label

1.69oz Willie's Cool Citrus Scent Hand Sanitizer Label

4oz Willie's Cool Citrus Scent Hand Sanitizer Label

8oz Willie's Cool Citrus Scent Hand Sanitizer Label

WILLIES COOL CITRUS SCENT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77167-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
ETHYL ACETOACETATE ETHYLENEGLYCOL KETAL (UNII: G5EXI4NID0)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77167-002-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/14/2020
2	NDC: 77167-002-02	118.29 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/14/2020
3	NDC: 77167-002-03	236.59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/14/2020	10/14/2021

Labeler - Willies Distillery (035580608)

Registrant - Willies Distillery (035580608)

Establishment
Name	Address	ID/FEI	Business Operations
Willies Distillery		035580608	manufacture(77167-002)

Revised: 10/2021

Document Id: ce578da3-7ca2-a97e-e053-2a95a90a4680

34390-5

Set id: aed17cfa-841f-5035-e053-2995a90ae937

Version: 5

Effective Time: 20211014