EENK SANITIZER WIPES- benzalkonium chloride solution

EENK SANITIZER WIPES by

Drug Labeling and Warnings

EENK SANITIZER WIPES by is a Otc medication manufactured, distributed, or labeled by CLEANIZ GROUP LLC, ZHANGZHOU WANSIKE ELECTRONICS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

■ To decrease bacteria on the skin that could cause disease

WARNINGS

For external use only

Do not use

In children less than two monthsof age.

On open skin wounds

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

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

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

Directions

Open package, pull wipe. Close package to retain moisture. Wet hands thoroughly with product. Allow to dry without rinsing

Supervise children under six years of age when using this product to avoid swallowing

Other Information

Keep container tightly closed in a dry, cool, and well ventilated place.

Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive ingredients

Alow Barbadensis leaf jiuce, Phenoxyethanol, Polysorbate 20, Propylene glycol, Tocopheryl Acetate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EENK SANITIZER WIPES 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81635-001
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81635-001-01	10 in 1 PACKET	03/12/2021
1		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 81635-001-02	20 in 1 PACKET	03/12/2021
2		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 81635-001-03	50 in 1 PACKET	03/12/2021
3		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 81635-001-04	60 in 1 CANISTER	03/12/2021
4		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
5	NDC: 81635-001-05	80 in 1 CANISTER	03/12/2021
5		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
6	NDC: 81635-001-06	100 in 1 CANISTER	03/12/2021
6		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
7	NDC: 81635-001-07	160 in 1 CANISTER	03/12/2021
7		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
8	NDC: 81635-001-08	300 in 1 CANISTER	03/12/2021
8		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
9	NDC: 81635-001-09	500 in 1 CANISTER	03/12/2021
9		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
10	NDC: 81635-001-10	800 in 1 CANISTER	03/12/2021
10		3.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/12/2021

Labeler - CLEANIZ GROUP LLC (117770489)

Establishment
Name	Address	ID/FEI	Business Operations
ZHANGZHOU WANSIKE ELECTRONICS CO., LTD		560452758	manufacture(81635-001)