MOSSY LEDGE SPIRITS- alcohol liquid

Mossy Ledge Spirits by

Drug Labeling and Warnings

Mossy Ledge Spirits by is a Otc medication manufactured, distributed, or labeled by Mossy Ledge Spirits. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredient[s] Purpose Alcohol 80% v/v.………………………………………….………….……….….……………………………………………...............................................Antiseptic

Uses

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Do not use

Do not use in children less than 2 months of age on open skin wounds

When using this product

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 doctor

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 safety information

Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Warning

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

REFERENCES

BOXED WARNING

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Drug Facts Label

REFERENCES

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.

INDICATIONS & USAGE

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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.

REFERENCES

complete label

PRINCIPAL DISPLAY PANEL

Alcohol Anticeptic 80% Topical Solution Hand Sanitizer Non-sterile Solution 3785 mL (1 Gallon)

Handcrafted by:

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INGREDIENTS AND APPEARANCE

MOSSY LEDGE SPIRITS 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74019-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3028 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	699 mL  in 3785 mL
GLYCERIN (UNII: PDC6A3C0OX)	54 mL  in 3785 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	4 mL  in 3785 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74019-123-12	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74019-123-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74019-123-23	208198 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
4	NDC: 74019-123-05	18927 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Mossy Ledge Spirits (105761797)

Establishment
Name	Address	ID/FEI	Business Operations
Mossy Ledge Spirits		105761797	manufacture(74019-123)