ISO-QUIN- alcohol gel 
Performance Health, 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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Iso-Quin Gel

Drug Facts

Active Ingredients

​Alcohol Denat 68% v/v

Purpose

​Antiseptic

Uses:

Helps decrease bacteria on the skin.  Recommended for repeated use.

Warnings

For external use only.

​Flammable - keep away from fire or flame.

When using this product

Use in a well-ventilated area.  Do not use in or near the eyes.  Discontinue use if irritation or redness develop.  If condition persists for more than 72 hours consult a doctor.  In case of eye contact, flush eyes with water and consult physician.

Directions:

Apply a small amount onto hands and rub briskly until dry.  Do not rinse.  Children under 6 years of age should be supervised when using this product.

Keep out of reach of children.

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

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Water, PEG-15 Cocamine, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

Questions?

+1-800 345-2231

Package Labeling:

IsoQuinGel

ISO-QUIN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-994
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL680 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-994-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
2NDC:59316-994-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/18/201712/31/2024
Labeler - Performance Health, LLC (794324061)

Revised: 8/2022
Document Id: e5b342cb-77eb-4555-e053-2a95a90ac7f1
Set id: 02933d92-2b12-4b25-866e-0f1d61f6bba5
Version: 5
Effective Time: 20220807
 
Performance Health, LLC