HAPPY FARM HAND SANITIZER- hand sanitizer liquid AETHERA HAND SANITIZER- hand sanitizer liquid

Aethera Hand Sanitizer by

Drug Labeling and Warnings

Aethera Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Happy Farm Botanicals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

Active Ingredients: Purpose

Ethyl Alcohol 80% v/v ..........Antiseptic

Purpose

Antiseptic

Use[s]

Use[s]

Healthcare Personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

Warnings

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

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 a 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 enought 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

Ohter 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

Principal Display Panel Front of Package

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAPPY FARM HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73964-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73964-018-08	236.588 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
2	NDC: 73964-018-12	354.882 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
3	NDC: 73964-018-16	473.176 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

AETHERA HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73964-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73964-019-02	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
2	NDC: 73964-019-12	354.882 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
3	NDC: 73964-019-16	473.176 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - Happy Farm Botanicals Inc. (022653140)

Establishment
Name	Address	ID/FEI	Business Operations
Happy Farm Botanicals Inc.		022653140	manufacture(73964-018, 73964-019) , pack(73964-018, 73964-019) , label(73964-018, 73964-019)