OTC Medication Information: ANTIBACTERIAL HANDWASH TROPICAL BEACH

ANTIBACTERIAL HANDWASH TROPICAL BEACH- benzalkonium chloride liquid
Universal Distribution Center 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 Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

USES

for hand washing to decrease bacteria on the skin.

Warning:

Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

Keep out of reach of children.

Directions

Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Ingredients:

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33

*Contains one or more of these ingredients.

Kill Germs and Odors

Distributed By:
Universal Distribution Center
96 Distribution Boulevard,
Edison, NJ 08817

Made in Turkey

Packaging

Tropical1
(click image for full-size original)

ANTIBACTERIAL HANDWASH TROPICAL BEACH
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-043
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
SODIUM LAURETH-3 SULFATE
SODIUM CHLORIDE
COCAMIDOPROPYL BETAINE
COCO MONOISOPROPANOLAMIDE
LAURETH-4
GLYCERIN
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
EDETATE SODIUM
CITRIC ACID MONOHYDRATE
SULISOBENZONE
.ALPHA.-TOCOPHEROL ACETATE
FD&C BLUE NO. 1
D&C RED NO. 33
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52000-043-01 400 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 08/01/2018
Labeler — Universal Distribution Center LLC (019180459)
Registrant — Universal Distribution Center LLC (019180459)
Establishment
Name Address ID/FEI Operations
Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim Sirketi 533139227 manufacture (52000-043)

Revised: 03/2020 Universal Distribution Center 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.

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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