SANNY- hand sanitizer solution

Sanny by

Drug Labeling and Warnings

Sanny by is a Otc medication manufactured, distributed, or labeled by Chervona, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Indredient(s)

Alcohol 80% v/v

Purpose

Use

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

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 serios condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 Information

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

Inactive Ingredients

Glycerin, hydrogen peroxide, purified water, lavandula angustifolia (lavender) oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANNY 
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80367-001
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
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.415 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80367-001-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020
2	NDC: 80367-001-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/2020

Labeler - Chervona, LLC (090741316)

Registrant - Chervona, LLC (090741316)

Establishment
Name	Address	ID/FEI	Business Operations
Chervona, LLC		090741316	relabel(80367-001) , manufacture(80367-001) , repack(80367-001)