HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS & FACE

HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS AND FACE by

Drug Labeling and Warnings

HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS AND FACE by is a Otc medication manufactured, distributed, or labeled by International Wholesale Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS AND FACE- benzalkonium chloride cloth 
International Wholesale Inc

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HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS & FACE

Drug Facts

Active Ingredient (by volume)

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 supervison.

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 (Alovera), Disodium EDTA, Citric Acid, Citronellol, Hexyl Cinnamal, Limonene, Linalool.

Package Labeling: 10wipes

Label

Package Labeling: 30 wipes

Label0

Package Labeling: 40 wipes

Label2

Package Labeling: 50 wipes

Label3

Package Labeling: 100 wipes

Box

HEALTH SMART ANTIBACTERIAL WET WIPES FOR HANDS AND FACE 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52862-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 (UNII: H4N855PNZ1)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52862-611-1010 in 1 PACKET06/22/202010/31/2022
13.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC: 52862-611-3030 in 1 PACKET06/22/202010/31/2022
23.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC: 52862-611-4040 in 1 PACKET10/10/202010/31/2022
33.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC: 52862-611-5050 in 1 PACKET10/10/202010/31/2022
43.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC: 52862-611-00100 in 1 PACKET10/15/202010/31/2022
53.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)06/22/202010/31/2022
Labeler - International Wholesale Inc (161872676)

Revised: 5/2024
Document Id: 19c137f8-c7c4-7b14-e063-6394a90a27f9
Set id: 02e6e4ee-cb47-4b8a-8bc6-0fa5e4c38ad4
Version: 5
Effective Time: 20240531