XTREME HAND SANITIZER- alcohol gel

Xtreme Hand Sanitizer by

Drug Labeling and Warnings

Xtreme 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]

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use

• Hand sanitizer to help reduce bacteria on the skin

Warnings

For External Use Only. Flammable.

Keep away from flames.  Keep out of eyes.  In case of contact with eyes, rinse eyes thoroughly with water.  Avoid contact with broken skin.  Do not inhale or ingest.

Stop use and contact a doctor if irritation develops or persists for more than 72 hours.

Keep out of reach of children.

If swallowed get immediate help or contact a poison control center right away.

Directions:

Apply to hands/skin, rub until dry.

Inactive Ingredients

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Triethanolamine, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A)

​Package Labeling: 74851-001-60

​Package Labeling: 74851-001-23

INGREDIENTS AND APPEARANCE

XTREME HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74851-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74851-001-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
2	NDC: 74851-001-23	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/08/2020

Labeler - Xtreme Personal Care Inc (081089201)