CLEANSE- benzalkonium chloride 0.13% soap
Medline Industries, 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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Made in USA of foreign and domestic materials for

Medline Industries,Inc.,

Mundelein, IL 60060 USA

1-800-MEDLINE

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops
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

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

Inactive ingredients

water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, sodium chloride, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, sodium sulfate, methylchloroisothiazolinone, methylisothiazolinone, red 40, yellow 5, red 33

Representative container label

CLEANSE ANTIBACTERIAL HAND SOAP

Helps kill harmful germs
Gentle enough for everyday use

Representative container label

CLEANSE
benzalkonium chloride 0.13% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-178
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
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-178-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2015	12/31/2018
2	NDC:53329-178-08	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2015	12/31/2018
3	NDC:53329-178-06	273 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2015	12/31/2018
4	NDC:53329-178-84	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2015	12/31/2018
5	NDC:53329-178-25	3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2015	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/19/2015	12/31/2018

Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2016

Document Id: 428644dd-b2d2-1675-e054-00144ff88e88

Set id: 22ca12db-3da0-6753-e054-00144ff8d46c

Version: 2

Effective Time: 20161130

Medline Industries, Inc.