PHX HAND SANITIZER- isopropyl alcohol gel 
Phx Hand Sanitizer 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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PH​x HAND SANITIZER

​Drug Facts

​Active Ingredient

Isopropyl alcohol 70% v/v

​Purpose

Antiseptic

​Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Use when soap and water are not available.

​Warnings

For external use only. Flammable. Keep away from heat and 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 thoroughly with water.

​Stop use and ask for a doctor ​if irritation 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 59-86˚F (15-30˚C)

• Avoid freezing and excessive heat above 104˚F (40˚C)

Inactive Ingredients: deionized water, polyethylene glycol, AMP - acrylates/vinyl isodecanoate crosspolymer, aloe barbadensis

leaf juice, glycerin, tocopheryl acetate (vitamin E acetate)

70% ISOPROPYL ALCOHOL WITH ALOE AND VITAMIN E

www.phxhandsan.com

​MADE IN USA

​PHx Hand Sanitizer

804 Summer Park, Suite 450

Stafford, TX 77477

Packaging

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PHX HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80304-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80304-100-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
2NDC:80304-100-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
3NDC:80304-100-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
4NDC:80304-100-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
5NDC:80304-100-32950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
6NDC:80304-100-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Phx Hand Sanitizer Llc (117545068)

Revised: 9/2020
Document Id: a746ea70-4de5-4651-a702-00f5db05cd63
Set id: eb8b3b44-8ccd-407c-8e9e-79a1a3012036
Version: 1
Effective Time: 20200901
 
Phx Hand Sanitizer Llc