ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by SHAOXING ELITE BIO-TECH CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial Agent

Use

Decreases bacteria on skin.

Warnings

For external use only.

Do not use

Do not use if you are allergic to any of the ingredients.

WHEN USING

When using this product, avoid contact with eyes and mouth. lf product gets in the eyes, flush thoroughly with water.

STOP USE

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Tear open the packet and remove wipe.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

Other information

Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping.

Children under 2 years. Consult a doctor prior to use.

Inactive ingredients

C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Vitamin E, Aloe Barbadensis Leaf Juice, Aqua.

Antibacterial Wipes Package Label

NDC: 81079-001-01

NDC: 81079-001-02

​NDC: 81079-001-03

​NDC: 81079-001-04

​NDC: 81079-001-05

​NDC: 81079-001-06

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81079-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81079-001-01	38 g in 1 BAG; Type 0: Not a Combination Product	11/15/2020
2	NDC: 81079-001-02	76 g in 1 BAG; Type 0: Not a Combination Product	11/15/2020
3	NDC: 81079-001-03	153 g in 1 BAG; Type 0: Not a Combination Product	11/15/2020
4	NDC: 81079-001-04	230 g in 1 BAG; Type 0: Not a Combination Product	11/16/2020
5	NDC: 81079-001-05	307 g in 1 BAG; Type 0: Not a Combination Product	11/16/2020
6	NDC: 81079-001-06	384 g in 1 BAG; Type 0: Not a Combination Product	11/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/15/2020

Labeler - SHAOXING ELITE BIO-TECH CO.,LTD. (546459425)

Registrant - SHAOXING ELITE BIO-TECH CO.,LTD. (546459425)

Establishment
Name	Address	ID/FEI	Business Operations
SHAOXING ELITE BIO-TECH CO.,LTD.		546459425	manufacture(81079-001)