ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER- benzalkonium chloride cloth

Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Orbizorb LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

• For hand washing to decrease bacteria on the skin

Warnings

For external use only

Do not use

in the eyes

Stop use and ask a doctor if

• irritation and redness develop.
• 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.

Directions

• Peel back the foil seal and pull the center wipe through the slot in the lid.
• Wet hands thoroughly with product and allow to dry without wiping.
• Close lid after use to prevent wipes from drying out.

Inactive ingredients

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

Package Labeling:

Package Labeling:2wipes

Package Labeling:40wipes

INGREDIENTS AND APPEARANCE

ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90119-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLOXALENE (UNII: V8B3K56SW0)
PEG-75 LANOLIN (UNII: 09179OX7TB)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BRONOPOL (UNII: 6PU1E16C9W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90119-001-80	80 in 1 CANISTER	08/30/2020
1		612.48 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 90119-001-02	2 in 1 PACKAGE	09/20/2020
2		7.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 90119-001-40	40 in 1 PACKAGE	09/20/2020
3		7.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/30/2020

Labeler - Orbizorb LLC (117447551)