OTC Medication Information: Redi Wipes

REDI WIPES- benzalkonium chloride patch
Radienz Living, LLC

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.

Active ingredients

Benalkonium chloride (0.115%)

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

For external use only.

Do Not Use

Do not use over large areas of the body or if you are allergic to any of these ingredients.

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

If irritation or redness develops and 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:

  • To use, peel back label, pull out wipe and firmly reseal label to maintain package moisture. Do not remove label.
  • Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and throw away. After cleansing, dispose of wipe in a trash receptacle. Rub hands together briskly to dry.

Inactive ingredients

Water, Behentrimonium Chloride, Dihydroxypropyl Peg-5 Linoleammonium Chloride, Glycereth-2 Cocoate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Phenoxyethanol, Potassium Sorbate, Fragrance

Other Information

*Kills 99.9% of germs that may cause illness, including E. Coli and MRSA in just 15 seconds.

RediWipes logo™, Free Of logo™, and Wind Energy/Artesian Glacial Aquifer Water logo™ are trademarks of U.S. Nonwovens Corp.
All rights reserved.


**This product is not manufactured or distributed by Edgewell Personal Care, owner of the registered trademark, Wet Ones®.


DISTRIBUTED BY: U.S. NONWOVENS CORP. 100 EMJAY BLVD., BRENTWOOD, NY 11717

Principal Display Panel

SANITIZING REDI WIPESTM

Compare to Wet Ones®**

ANTIBACTERIAL HAND WIPES

FRESH SCENT

ALCOHOL FREE

KILLS 99.9% OF GERMS*

15 Soft Wipes

7 IN x 6 IN

(17.78 cm x 15.24 cm)

Label
(click image for full-size original)
REDI WIPES
benzalkonium chloride patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52553-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.115 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
WATER
BEHENTRIMONIUM CHLORIDE
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE
GLYCERETH-2
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52553-004-15 15 PATCH in 1 PACKAGE contains a PATCH
1 0.115 mg in 1 PATCH This package is contained within the PACKAGE (52553-004-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/16/2021
Labeler — Radienz Living, LLC (117451061)
Registrant — Radienz Living, LLC (080453184)
Establishment
Name Address ID/FEI Operations
Radienz Living, LLC 080453184 manufacture (52553-004)

Revised: 04/2021 Radienz Living, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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