SOFT N SURE HAND SANITIZER- benzalkonium chloride solution

Soft N Sure Hand Sanitizer by

Drug Labeling and Warnings

Soft N Sure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SC Johnson Professional USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

BENZALKONIUM CHLORIDE, 0.13%

Purpose

Antibacterial

Uses

for hand sanitizing to reduce bacterial on the skin

Warnings

For external use only

When using this product

avoid contact with the eyes. In case of eye contact, flush with water

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.   

Directions

apply one shot to dry hands, rub into skin

no rinsing required

Inactive ingredients

ALOE BARBADENSIS LEAF JUICE, AQUA (WATER), COCAMIDOPROPYL BETAINE, LAURAMINE OXIDE, MAGNESIUM CHLORIDE, MAGNESIUM NITRATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, PROPYLENE GLYCOL, TETRASODIUM EDTA

PRINCIPAL DISPLAY PANEL

Soft ‘N Sure®
NDC: 11084-007-27
Hand Sanitizer
Non-Alcohol Antiseptic Handrub
Excellent Moisturization
Fast-acting
CHG Compatible
1 Liter (33.8 fl oz) (1.05 qt)
DebMed USA, LLC. Charlotte, NC 28217 1-866-783-0422 www.debmed.com
Made in the USA.
Open for
Drug Facts
Dye & Fragrance Free
Stock# : 101961

INGREDIENTS AND APPEARANCE

SOFT N SURE HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-007
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-007-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017
2	NDC: 11084-007-12	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2017

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-007)