4 HOUR POWER HAND SANITIZER- benzalkonium chloride liquid

4 Hour Power Hand Sanitizer by

Drug Labeling and Warnings

4 Hour Power Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guide Energy Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use[s]

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

FOR EXTERNAL USE ONLY. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

Directions

Place enough product on your palm to thoroughly cover your hands. Rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Other information

Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Keep out of extreme temperatures.

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Lauramine Oxide, Dimethyltetradecylamine Oxide, DMDM Hydantoin (preservative), Fragrance*
*may contain this ingredient

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

ALCOHOL FREE

FRESH ALOE SCENT

NON-FLAMMABLE

DYE FREE

NON-IRRITATING

MOISTURIZING FORMULA

NO STING

Long Lasting, Kills 99.9% of Germs for Up to 4 Hours

Outlasts Alcohol-Based Sanitizers by Persisting on Skin

Alcohol Free Formula Won't Dry Hands, Sting, or Cause Cracking

Leaves Skin Feeling Nourished and Moisturized

Paraben-Free, Sulfate-Free, Phthalate-Free

Foaming Formula

Packaging

INGREDIENTS AND APPEARANCE

4 HOUR POWER HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77042-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MYRISTAMINE OXIDE (UNII: J086PM3RRT)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77042-440-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2021
2	NDC: 77042-440-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2021
3	NDC: 77042-440-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/05/2021

Labeler - Guide Energy Solutions LLC (117045830)

Establishment
Name	Address	ID/FEI	Business Operations
Guide Energy Solutions LLC		117045830	manufacture(77042-440) , pack(77042-440)