DEB INSTANTFOAM PURE NON-ALCOHOL HAND SANITIZER- benzalkonium chloride liquid liquid
Deb USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

BENZALKONIUM CHLORIDE, 0.13%

Purpose

Antibacterial

Uses

for hand sanitizing to reduce bacteria on the skin

Warnings

For external use only

When using this product

avoid contact with 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

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

deb stoko

Deb InstantFOAM PURE

Non-Alcohol - Dye & Fragrance Free Hand Sanitizer

Antiséptico para manos en espuma - sin alcohol, sin colorante y sin perfume

DISINFECT

NON-ALCOHOL

DCN8901/0415

deb

Deb USA, Inc. Charlotte,

NC 28217. 1-800-248-7190

www.debgroup.com

Made in USA

1 L

33.8 fl oz

55857-DCN8901 InstantFOAM Nonalcohol PURE-1L-V6.jpg

DEB INSTANTFOAM PURE NON-ALCOHOL HAND SANITIZER
benzalkonium chloride liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-150
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-150-01	0.047 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015	12/01/2022
2	NDC:11084-150-40	0.4 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015	12/01/2022
3	NDC:11084-150-27	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015	12/01/2022
4	NDC:11084-150-12	1.2 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2015	12/01/2022
5	NDC:11084-150-99	1230 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 1: Convenience Kit of Co-Package	04/15/2015	12/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2015	12/01/2022

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-150)

Name	Address	ID/FEI	Business Operations
Establishment
Deb Worldwide Healthcare Inc.		205662831	repack(11084-150)

Revised: 12/2017

Document Id: 3c488d69-ede3-4582-ad58-f597b517e059

Set id: 978a29db-a7e0-41ed-97ae-8cbdfaae46b0

Version: 3

Effective Time: 20171221

Deb USA, Inc.