WIPE OUT ANTIBACTERIAL WIPES FRESH SCENT- benzalkonium chloride solution

WIPE OUT Antibacterial Wipes Fresh Scent by

Drug Labeling and Warnings

WIPE OUT Antibacterial Wipes Fresh Scent by is a Otc medication manufactured, distributed, or labeled by TZUMI INNOVATIONS LLC, TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NA

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

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

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

Wet hands thoroughly with product and 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: 32F to 104F (0C to 40C)

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WIPE OUT ANTIBACTERIAL WIPES FRESH SCENT 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77878-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	6.8 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77878-010-01	20 in 1 BAG; Type 0: Not a Combination Product	06/25/2020
2	NDC: 77878-010-02	80 in 1 CANISTER; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/25/2020

Labeler - TZUMI INNOVATIONS LLC (117426322)

Establishment
Name	Address	ID/FEI	Business Operations
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY		679914791	manufacture(77878-010)