HAND SANITIZER- ethyl alcohol liquid 
STILL VALLEY SPIRITS 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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STILL VALLEY SPIRITS Hand Sanitizer

Drug Facts

Active ingredient(s)

Denatured Ethyl Alcohol 80% v/v 

Purpose(s)

Antiseptic

Uses(s)

Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap or water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• on 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 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

• Spray 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 15-30°C (59-86°F)

• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredient(s)

• Distilled or Boiled Water, Hydrogen Peroxide, Glycerin

Formula Based on FDA Compounding Guidlines for consumer and healthcare personnel use, issued March 2020.

Best used for refilling spray bottles.

Not for human consumption. External use only.

Produced by Still Valley Spirits LLC Puyallup, WA

Contents may separate naturally. Shake well.

Packaging

IMAGE

HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78684-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78684-080-01750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - STILL VALLEY SPIRITS LLC (122659099)
Establishment
NameAddressID/FEIBusiness Operations
STILL VALLEY SPIRITS LLC122659099manufacture(78684-080)

Revised: 6/2020
Document Id: 9f12ea0f-4781-4136-9152-e3de29c24321
Set id: 8a60715f-a3f3-4213-bcc5-ecba05a15be1
Version: 2
Effective Time: 20200623
 
STILL VALLEY SPIRITS LLC