WIPE OUT ANTIBACTERIAL WIPES FRESH SCENT- benzalkonium chloride cloth

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 Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

WIPE OUT Antibacterial Wipes Fresh Scent

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

Purpose: Antiseptic

PURPOSE

Antiseptic, WIPE OUT Antibacterial Wipes Fresh Scent

INDICATIONS & USAGE

WIPE OUT Antibacterial Wipes Fresh Scent to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away from heat or flame

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 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

STOP USE

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

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

DOSAGE & ADMINISTRATION

Wipe the surface of the skin and let it dry naturally.
Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WIPE OUT ANTIBACTERIAL WIPES FRESH SCENT 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80404-301
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   in 100

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80404-301-01	1 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
2	NDC: 80404-301-02	10 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
3	NDC: 80404-301-03	20 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
4	NDC: 80404-301-04	40 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
5	NDC: 80404-301-05	60 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
6	NDC: 80404-301-06	80 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
7	NDC: 80404-301-07	100 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
8	NDC: 80404-301-08	120 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
9	NDC: 80404-301-09	200 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
10	NDC: 80404-301-10	400 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
11	NDC: 80404-301-11	500 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
12	NDC: 80404-301-12	600 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
13	NDC: 80404-301-13	800 in 1 BAG; Type 0: Not a Combination Product	09/02/2020
14	NDC: 80404-301-14	1000 in 1 BAG; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/02/2020

Labeler - Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. (546457554)

Establishment
Name	Address	ID/FEI	Business Operations
Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.		546457554	manufacture(80404-301)