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

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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

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 2 oz 59 mL

Gentle Hands Sanitizer Spray Calming Citrus 3.4 oz 100 mL

Gentle Hands Sanitizer Spray Calming Citrus 3.4 oz 100 mL

Gentle Hands Sanitizer Spray Calming Citrus 32 oz 946.35 mL

Gentle Hands Sanitizer Spray Calming Citrus 32 oz 946.35 mL

GENTLE HANDS SANITIZER CALMING CITRUS 
hand sanitizer spray calming citrus liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74299-281
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74299-281-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
2NDC:74299-281-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
3NDC:74299-281-03946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Southern Distilling Company LLC (046275910)
Establishment
NameAddressID/FEIBusiness Operations
Southern Distilling Company LLC046275910manufacture(74299-281)

Revised: 9/2020
Document Id: b0b50c17-cbf0-3dbe-e053-2995a90a2d90
Set id: b0b50c17-cbef-3dbe-e053-2995a90a2d90
Version: 1
Effective Time: 20200901
 
Southern Distilling Company LLC