Xtreme Personal Care Hand Sanitizer Gel

Xtreme Personal Care Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

XTREME PERSONAL CARE HAND SANITIZER- alcohol gel 
Xtreme Personal Care 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 Personal Care Hand Sanitizer Gel

Drug Facts

Active ingredient(s)

Alcohol 70%

Purpose

Antimicrobial

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Flammable. Keep away from heat or flame.

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

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 immediate medical help or contact a poison control center right away.

Directions

Apply onto hands/skin, rub until dry.

Inactive ingredients

Water, Propylene Glycol, Glycerin, Carbomer, Fragrance, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Labeling:

Bottle

XTREME PERSONAL CARE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74851-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74851-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/202012/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/01/202012/22/2022
Labeler - Xtreme Personal Care Inc (081089201)

Revised: 3/2022
Document Id: db5fa36e-b8f4-5ff7-e053-2a95a90a4f6f
Set id: b0775a9f-318e-6d82-e053-2a95a90a724b
Version: 2
Effective Time: 20220329