Xtreme Kleen Hand Sanitizer

Xtreme Kleen Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

XTREME KLEEN HAND SANITIZER- 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 Hand Sanitizer

Active Ingredient

Ethyl 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 copolymer, glycerin, tocopheryl acetate, phenoxyethanol, isopropyl myristate, propylene glycol, aminomethyl propanol

Xtreme Kleen Hand Sanitizer

XTREME KLEEN HAND SANITIZER 
ethyl alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79532-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	165.2 mL  in 236 mL

Inactive Ingredients
Ingredient Name	Strength
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)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79532-001-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 79532-001-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Dyno Manufacturing, Inc (015718256)

Registrant - Dyno Manufacturing, Inc (015718256)

Revised: 1/2022

Document Id: d65578bb-6283-51ac-e053-2995a90aa07d

34390-5

Set id: ac100448-2270-9e02-e053-2a95a90aa3ac

Version: 2

Effective Time: 20220124