COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER CONTINUOUS SPRAY

COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER by

Drug Labeling and Warnings

COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by FRUIT OF THE EARTH, INC., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER- alcohol aerosol, spray 
FRUIT OF THE EARTH, INC.

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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COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER CONTINUOUS SPRAY

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not use while smoking.

Do not use

  • on 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.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatufes above 120ºF.

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.

Directions

  • spray enough product in palm to thoroughly cover your hands
  • rub hands together briskly until dry
  • children under 6 years of age should be supervised when using this product.

Other information

  • may discolo or damage some fabrics/materials or surfaces.
  • Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

water, glycerin, aloe barbadensis leaf juice, tocopheryl acetate

Questions or comments?

1-800-990-3764

COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER CONTINUOUS SPRAY

5.5 FL OZ. (153mL)

NDC: 62217-287-37

CA61416

COOLA BARE HANDS BY BARE REPUBLIC HAND SANITIZER 
alcohol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62217-287
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62217-287-37153 mL in 1 CAN; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-287)

Revised: 6/2020
Document Id: a9f2709e-a03a-d934-e053-2a95a90a336b
Set id: a9f27f98-fba8-d972-e053-2a95a90a9dbf
Version: 1
Effective Time: 20200610