EVOWELL HAND SANITIZER WITH ALOE VERA- benzalkonium chloride liquid

Evowell Hand Sanitizer with Aloe Vera by

Drug Labeling and Warnings

Evowell Hand Sanitizer with Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Windmill Health Products, LLC, Cemi International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial and First aid antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

Directions

Pump onto hands as needed. Rub briskly together until dry. Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

Inactive ingredients

ionized water, aloe vera, carbamide

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Distributed by: EvoWell™ 10 Henderson Drive, West Caldwell, NJ 07006

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

EVOWELL™
WELLNESS EVOLVED

Hand Sanitizer
with Aloe Vera

EXTENDED PROTECTION*

Eliminates 99.99% of Germs

alcohol-free
triclosan-free & fragrance-free

Non-Irritating Non-Stinging

Benzalkonium Chloride 0.13%

Antimicrobial
& Antiseptic

2.0 FL OZ
(59 mL)

INGREDIENTS AND APPEARANCE

EVOWELL HAND SANITIZER WITH ALOE VERA 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74154-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	130 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
aloe vera leaf (UNII: ZY81Z83H0X)
urea (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74154-005-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	04/27/2020

Labeler - Windmill Health Products, LLC (831136267)

Establishment
Name	Address	ID/FEI	Business Operations
Cemi International		015038336	MANUFACTURE(74154-005)