HEALTH SMART ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

Health Smart Antibacterial Wet Wipes by

Drug Labeling and Warnings

Health Smart Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by International Wholesale, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

• 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

do not get into eyes. If contact occurs, rinse 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.

For children under 2 years ask a doctor before use. For children use under adult supervision.

Directions

Do not expose to direct sunlight, preferably place them in a cool place. Do not use on furniture. Do not flush down toilets, dispose in trash receptacles.

Remove lid and open the seal. Pull up the corner of the center sheet, twist it and thread through the dispenser split in the lid.Pull sheet out at an angle. When finished close lid flap to retain moisture.

Inactive Ingredients:

Aqua, Phenoxyethanol, Propylene Glycol, Polysorbate 20, Glycerin, PEG-7 Glyceryl Cocoate, Cocamidopropyl Betaine, Parfum, Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Aloe Barbadensis Leaf Extract (Aloevera), Disodium EDTA, Citric Acid, Citronellol, Hexyl Cinnamal, Limonene, Linalool.

Package Labeling:50count

Package Labeling:100count

INGREDIENTS AND APPEARANCE

HEALTH SMART ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-613-01	50 in 1 BAG	10/01/2020
1		3.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 52862-613-02	100 in 1 BAG	10/01/2020
2		3.2 g 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)	10/01/2020

Labeler - International Wholesale, Inc. (161872676)