GENTLE HANDS SANITIZER CALMING CITRUS- hand sanitizer spray calming citrus liquid

Gentle Hands Sanitizer Calming Citrus by

Drug Labeling and Warnings

Gentle Hands Sanitizer Calming Citrus by is a Otc medication manufactured, distributed, or labeled by Southern Distilling Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are 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

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.

STOP USE

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 or 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 USP, fragrance containing essential oil

Gentle Hands Sanitizer Spray Calming Citrus 2 oz 59 mL

Gentle Hands Sanitizer Spray Calming Citrus 3.4 oz 100 mL

Gentle Hands Sanitizer Spray Calming Citrus 32 oz 946.35 mL

INGREDIENTS AND APPEARANCE

GENTLE HANDS SANITIZER CALMING CITRUS 
hand sanitizer spray calming citrus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74299-281
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)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74299-281-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020
2	NDC: 74299-281-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020
3	NDC: 74299-281-03	946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - Southern Distilling Company LLC (046275910)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Distilling Company LLC		046275910	manufacture(74299-281)