Xtreme Kleen Moisturizing Advanced Gel Hand Sanitizer Unscented

Xtreme Kleen Moisturizing Advanced Hand Sanitizer Unscented by

Drug Labeling and Warnings

Xtreme Kleen Moisturizing Advanced Hand Sanitizer Unscented by is a Otc medication manufactured, distributed, or labeled by Dyno Manufacturing, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XTREME KLEEN MOISTURIZING ADVANCED HAND SANITIZER UNSCENTED- ethyl alcohol 70% gel 
Dyno Manufacturing, 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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Xtreme Kleen Moisturizing Advanced Gel Hand Sanitizer Unscented

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on the skin 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 this product

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

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

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

Water, Acrylates/C10-30 alkyl acrylate crosspolymer,propylene glycol, phenoxyethenol,isopropyl myristate, glycerin,Tertiary Butyl Alcohol, aminomethyl propanol, tocopheryl acetate,Denatonium Benzoate

Xtreme Kleen Moisturizing Advanced Gel Hand Sanitizer

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XTREME KLEEN MOISTURIZING ADVANCED HAND SANITIZER UNSCENTED 
ethyl alcohol 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79532-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.2 mL  in 236 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79532-002-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
2NDC: 79532-002-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
3NDC: 79532-002-641893 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
4NDC: 79532-002-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Dyno Manufacturing, Inc (015718256)
Registrant - Dyno Manufacturing, Inc (015718256)

Revised: 2/2022
Document Id: d7add253-93b6-3613-e053-2995a90a9aeb
Set id: b2e79011-30dd-4507-e053-2995a90a59e8
Version: 2
Effective Time: 20220210