ANTIBACTERIAL WIPES UNSCENTED- benzalkonium chloride solution

ANTIBACTERIAL WIPES UNSCENTED by

Drug Labeling and Warnings

ANTIBACTERIAL WIPES UNSCENTED by is a Otc medication manufactured, distributed, or labeled by ZHANGZHOU WANSIKE ELECTRONICS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Warnings

FOR EXTERNAL USE ONLY.

Do not use
·in children less than 2 months of age
·on open skin wounds

When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

Do not use

Do not use
·in children less than 2 months of age
·on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DIRECTIONS
·Open package.Pull wipe.Close package to retain moisture wet hands thoroughly with product.Allow to dry without rinsing.
·Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and exessive heat aboce 40C (104F)

Inactive ingredients

INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Juice, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

80593-006-01 10 solution in 1 package

80593-006-02 20 solution in 1 package

80593-006-03 50 solution in 1 package

80593-006-04 80 solution in 1 package

80593-006-05 100 solution in 1 package

80593-006-06 40 solution in 1 canister

80593-006-07 80 solution in 1 canister

80593-006-08 100 solution in 1 canister

80593-006-09 300 solution in 1 canister

80593-006-10 500 solution in 1 canister

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES UNSCENTED 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80593-006
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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80593-006-01	10 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 80593-006-03	50 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 80593-006-09	300 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
4	NDC: 80593-006-04	80 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 80593-006-02	20 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 80593-006-05	100 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 80593-006-06	40 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
8	NDC: 80593-006-07	80 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
9	NDC: 80593-006-10	500 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
10	NDC: 80593-006-08	100 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - ZHANGZHOU WANSIKE ELECTRONICS CO., LTD (560452758)

Establishment
Name	Address	ID/FEI	Business Operations
ZHANGZHOU WANSIKE ELECTRONICS CO., LTD		560452758	manufacture(80593-006)