Distill Brand Sanitizing Elixir

Distill Brand Sanitizing by

Drug Labeling and Warnings

Distill Brand Sanitizing by is a Otc medication manufactured, distributed, or labeled by OCG Products, LLC, Redmont Distilling Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISTILL BRAND SANITIZING- alcohol liquid 
OCG Products, 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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Distill Brand Sanitizing Elixir

Drug Facts

Active Ingredient(s)

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause diease. For use when soap & 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 & mouth. In case of contact with eyes, rinse eyes thoroughly with water

Stop use & 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.

Directins

• 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 59-86°F.
• Avoid freezing & excessive heat above 104°F.
• May damage plastics and/or discolor fabrics.

Inactive Ingredients

hydrogen peroxide, purified water USP, rosemary mint essential oil.

Package Labeling

DISTILL BRAND SANITIZING 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78118-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78118-000-00	375 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020	12/31/2021

Labeler - OCG Products, LLC (966912201)

Establishment
Name	Address	ID/FEI	Business Operations
Redmont Distilling Company, LLC		084878898	manufacture(78118-000)

Revised: 10/2021

Document Id: ce26d341-835f-6b20-e053-2a95a90a6125

34390-5

Set id: 7cc6decb-acbd-4aae-b7af-7b03ec93bf59

Version: 3

Effective Time: 20211012