REMEDY ANTIMICROBIAL CLEANSER- benzalkonium chloride solution
Medline Industries, LP

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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158 Remedy Antimicrobial Cleanser

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antimicrobial

Uses

A no-rinse topical antiseptic that protects against microbial contamination

Warnings

For External Use Only.

Do not use

in the eyes or apply over large areas of the body.

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

When using this product

do not use longer than 1 week unless directed by a doctor
do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days and occur again within a few days.

Keep out of reach of children.

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

Directions

Spray soiled and/ or odorous (body and perineal) areas.
Gently wipe clean.
Repeat as necessary until all soils are removed and skin is clean.
Pat dry. No rinsing necessary.
Apply a Remedy protectant cream or paste as necessary.

Other information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl- L-cysteine, Niacinamide, Polysorbate 20, Propylene Glycol, Propylparaben, Pyridoxine HCl, Tetrasodium EDTA, Vanillin, Water.

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for Medline Industries, Inc., Mundelein, IL 60060 www.medline.com 1-800-MEDLINE. Made in USA.

Package Label

Label 158

REMEDY ANTIMICROBIAL CLEANSER
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-158
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	120 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ORANGE OIL (UNII: AKN3KSD11B)
MANDARIN OIL (UNII: NJO720F72R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
PROLINE (UNII: 9DLQ4CIU6V)
TAURINE (UNII: 1EQV5MLY3D)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
EDETATE SODIUM (UNII: MP1J8420LU)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-158-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/08/2018	10/06/2023
2	NDC:53329-158-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/08/2018	12/14/2023
3	NDC:53329-158-34	148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/08/2018	09/21/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/01/2008	12/14/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 10/2022

Document Id: ebe21154-00f8-d501-e053-2a95a90ab7c8

Set id: bde15cd9-9a93-419f-8da4-9d7b9a1645b4

Version: 10

Effective Time: 20221025

Medline Industries, LP