JOLO ACTIVE- alcohol gel 
FUSION ACCELERATE, 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

Alcohol 62% v/v

Purpose

Antiseptic

Use

To sanitize hands without requiring water or a rinse – Kills 99.9% of most common bacteria in 15 seconds

Warnings

For external use only

Flammable

Do not use near 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 throughly with water.

Stop use and ask a doctor

if irritation or rash occurs.

They 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 atv 1-800-222-1222

Directions

Apply gel liberally to unsoiled hands and rub in thoroughly

Allow to dry without wiping or rinsing

Other information

Inactive ingredients

Water, Aloe barbadensis Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Yellow 10, Yellow 5, Blue 1.

Product label

image description

JOLO ACTIVE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79989-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79989-001-01150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2020
Labeler - FUSION ACCELERATE, LLC (081331914)

Revised: 9/2020
Document Id: 10559a50-d321-432e-a5e7-d4bdb774527d
Set id: d193a1fc-95ba-4979-bd10-6cbcf26044b0
Version: 1
Effective Time: 20200911
 
FUSION ACCELERATE, LLC