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)

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

To decrease bacteria on the skin that could cause disease

Warnings

For external use only

When using this product
keep out of eyes.In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin

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

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

Control Center right away.

Do not use

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WHEN USING

keep out of eyes.In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin

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

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

Control Center right away.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Control Center right away.

Directions

allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

keep containers tightly closed in a dry, cool and well-ventilated place.
recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Inactive ingredients

aloe barbadensis leaf juice, phenoxyethanol, polysorbate 20, propylene glycol,

tocopheryl acetate, water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES UNSCENTED 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80593-003
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80593-003-01	10 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 80593-003-03	50 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 80593-003-02	20 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 80593-003-04	70 in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 80593-003-05	80 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
6	NDC: 80593-003-08	300 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
7	NDC: 80593-003-07	160 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
8	NDC: 80593-003-09	500 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
9	NDC: 80593-003-06	100 in 1 CANISTER; Type 0: Not a Combination Product	03/30/2020
10	NDC: 80593-003-10	800 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(80593-003)