CLEANSE- benzalkonium chloride 0.13% solution

Cleanse by

Drug Labeling and Warnings

Cleanse by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

benzophenone-4, cocamidopropyl betaine, citric acid, disteareth-75 IPDI, fragrance, glycerin, lauramine oxide, lauramidopropylamine oxide, myristamidopropylamine oxide, PEG-150 distearate, red 40, red 33, sodium benzoate, sodium chloride, tetrasodium EDTA, water, yellow 5

Questions?

Call 1-800-MEDLINE

SPL UNCLASSIFIED SECTION

www.medline.com
©2018 Medline Industries, Inc., Made in USA of foreign and

domestic materials for Medline Industries, Inc., Three Lakes Drive,

Northfield, IL 60093 USA. 1-800-MEDLINE RK18VJO

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEANSE 
benzalkonium chloride 0.13% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-177
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-177-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2016
2	NDC: 53329-177-08	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2016
3	NDC: 53329-177-84	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2016
4	NDC: 53329-177-25	3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2016
5	NDC: 53329-177-06	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/19/2016

Labeler - Medline Industries, Inc. (025460908)