OTC Medication Information: Soft Care Sentry

SOFT CARE SENTRY — benzalkonium chloride solution
Diversey, 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.

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

For hands to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Do not ingest

Do not use in the eyes.

When using this product do not get in eyes.

In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation and redness develop.

If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Do not use if you are allergic to any ingredients.

Directions

Apply a small amount to hands, add water and lather by rubbing hands together for 20 seconds, rinse with potable water.

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0801277

FOR COMMERCIAL USE

See container for Lot Code and Expiry Date.

Store in a cool dry place.

Inactive ingredients

Water, Cocamidopropyl betaine, Cocamidopropyl PG-Dimmonium Chloride Phosphate, Laurtrimonium Chloride, PEG-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

Questions or comments?

1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

www.diversey.com

Diversey

NDC 64536-1948-3

Soft Care Sentry

Foaming Antibacterial Hand Soap

For commercial use

NSF

Nonfood Compounds

Program Listed E2

Registration 156691

(L) Exp.

Net Contents

1.3 L / 1.37 U.S. Qt.

SKU: 101100320

container labelFPM1
(click image for full-size original)
container labelBPM3
(click image for full-size original)
SOFT CARE SENTRY
benzalkonium chloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64536-1948
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE
LAURTRIMONIUM CHLORIDE
PEG-6 COCAMIDE
IODOPROPYNYL BUTYLCARBAMATE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64536-1948-3 1300 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/19/2018
Labeler — Diversey, Inc. (018240817)
Establishment
Name Address ID/FEI Operations
KUTOL PRODUCTS COMPANY 004236139 manufacture (64536-1948)

Revised: 03/2018 Diversey, Inc.

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.

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.

Terms of Use | Copyright © 2024. All Rights Reserved.