DEB INSTANTFOAM NON-ALCOHOL PURE- benzalkonium chloride liquid
SC Johnson Professional 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.

----------

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

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

deb stoko

Deb InstantFOAM(R) Non-Alcohol PURE

Dye & Fragrance Free Hand Sanitizer

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

SANITIZE

NON-ALCOHOL

DCN8901/1116

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-V9.jpg

DEB INSTANTFOAM NON-ALCOHOL PURE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-001-01	47 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2016	12/31/2022
2	NDC:11084-001-40	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2016	08/04/2023
3	NDC:11084-001-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2016	09/29/2023
4	NDC:11084-001-12	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2016	09/28/2023
5	NDC:11084-001-99	1230000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	09/07/2016	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/07/2016	09/29/2023

Labeler - SC Johnson Professional USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
SC Johnson Professional CA Inc.		203765300	Manufacture(11084-001)

Revised: 12/2022

Document Id: e88a3489-a6d4-4047-954f-251581b0a5d0

Set id: 6b03bc9d-3f3e-4b59-bef8-d68335233a9c

Version: 5

Effective Time: 20221222

SC Johnson Professional USA, Inc.