THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E- benzalkonium chloride cloth

Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E by

Drug Labeling and Warnings

Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only.

Do not use

• over large areas of the body
• if you are allergic to any of the ingredients

When using this product

avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if

irritation or rash develops and continues 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

• for adults and children of 2 years and over
• children under 2 year ask a doctor before use
• allow to dry without wiping

Other information

store at room temperature

Inactive ingredients

Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Polyaminopropyl Biguanide, Disodium EDTA, Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol, Tocopheryl Acetate

Package Labeling:

INGREDIENTS AND APPEARANCE

THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BRONOPOL (UNII: 6PU1E16C9W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-007-20	20 in 1 BAG	11/10/2020
1		3.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/10/2020

Labeler - Fourstar Group USA, Inc. (140099503)