OTC Medication Information: TopCare Antibacterial Hand Light Moisturizers

TOPCARE ANTIBACTERIAL HAND LIGHT MOISTURIZERS- benzalkonium chloride soap
Abaco Partners LLC DBA Surefil

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.

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

for hand washing, reduces germs on skin

Warnings

For external use only–hands only

When using this product

  • avoid contact with eyes. If case of contact, rinse eyes thoroughly with water.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash hands and rinse.

Inactive Ingredients

Water, Myristyl Amidopropyl Amine Oxide, Cetrimonium Chloride, Glycerin, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Citric Acid, Fragrance, Benzalkonium Chloride, Methylchloroisothiazolinone, Tetrasodium EDTA, D&C Red 33, FD&C Red 40, FD&C Yellow 5

Questions?

Call 1-888-423-0139

Other information

store at 20°C — 25°C (68°F — 77°F)

DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL — 221 mL Bottle Label

TopCare
everyday

antibacterial
hand soap
with light moisturizer

gently cleans & protects

COMPARE
TO SOFTSOAP®
ANTIBACTERIAL
HAND SOAP WITH
MOISTURIZERS*

fresh
& clean

7.5 FL OZ (221 mL)

PRINCIPAL DISPLAY PANEL -- 221 mL Bottle Label
(click image for full-size original)
TOPCARE ANTIBACTERIAL HAND LIGHT MOISTURIZERS
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:20890-0040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 2.34 mg in 1.8 mL
Inactive Ingredients
Ingredient Name Strength
Water
Cetrimonium Chloride
Glycerin
Lauramidopropylamine Oxide
COCO MONOETHANOLAMIDE
Sodium Chloride
PEG-120 METHYL GLUCOSE DIOLEATE
Citric Acid Monohydrate
EDETATE SODIUM
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C RED NO. 40
FD&C YELLOW NO. 5
D&C RED NO. 33
Product Characteristics
Color ORANGE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:20890-0040-1 221 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 part333E 01/15/2015
Labeler — Abaco Partners LLC DBA Surefil (964809417)
Establishment
Name Address ID/FEI Operations
Abaco Partners LLC DBA Surefil 964809417 MANUFACTURE (20890-0040)

Revised: 10/2019 Abaco Partners LLC DBA Surefil

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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