ANTIBACTERIAL WET WIPES- benzalkonium chloride swab
Yuyao Jessie Commodity Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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51414- 400 Antibacterial Wet Wipes

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for hand washing to decrease bacteria on skin

WARNINGS

For External use only.

Do not use if you are allergic to any of the ingredients.

When using this product Do not get into eyes,if contact occurs ,rinse throughly with water.

Discontinue use if irritation or redness develops if condition persists for more than 72 hours consults a physician.

keep out of reach of children

keep out of reach of children unless under adult supervision .if seallowed ,get medical help or contact a Poison Control Center immediately.

Directions

Thoroughly wipe hands or face with wipe,Discard in trash receptacle;do not flush.Be sure to reseal label complete to retain moisture

Inactive ingredients

WATER PROPYLENE GLYCOL OCTHILINONE .ALPHA.-TOCOPHEROL

section text here

ANTIBACTERIAL WET WIPES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51414-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTHILINONE (UNII: 4LFS24GD0V)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51414-400-01	1 in 1 BOTTLE	01/06/2018
1		10 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:51414-400-02	5 in 1 BOTTLE	01/06/2018
2		4 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:51414-400-03	10 in 1 BOTTLE	01/06/2018
3		3.5 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:51414-400-04	15 in 1 BOTTLE	01/06/2018
4		3 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:51414-400-05	20 in 1 BOTTLE	01/06/2018
5		3 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC:51414-400-06	25 in 1 BOTTLE	01/06/2018
6		3 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC:51414-400-07	30 in 1 BOTTLE	01/06/2018
7		2.5 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC:51414-400-08	35 in 1 BOTTLE	01/05/2018
8		2.5 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC:51414-400-09	40 in 1 BOTTLE	01/06/2018
9		2.5 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC:51414-400-10	45 in 1 BOTTLE	01/06/2018
10		2.5 g in 1 POUCH; Type 0: Not a Combination Product
11	NDC:51414-400-11	50 in 1 BOTTLE	01/06/2018
11		2.5 g in 1 POUCH; Type 0: Not a Combination Product
12	NDC:51414-400-12	60 in 1 BOTTLE	01/06/2018
12		2.5 g in 1 POUCH; Type 0: Not a Combination Product
13	NDC:51414-400-13	70 in 1 BOTTLE	01/06/2018
13		2.5 g in 1 POUCH; Type 0: Not a Combination Product
14	NDC:51414-400-14	80 in 1 BOTTLE	01/06/2018
14		2.5 g in 1 POUCH; Type 0: Not a Combination Product
15	NDC:51414-400-15	90 in 1 BOTTLE	01/06/2018
15		2.5 g in 1 POUCH; Type 0: Not a Combination Product
16	NDC:51414-400-16	100 in 1 BOTTLE	01/06/2018
16		2.5 g in 1 POUCH; Type 0: Not a Combination Product
17	NDC:51414-400-17	1 in 1 PACKAGE	01/06/2018
17		3 g in 1 POUCH; Type 0: Not a Combination Product
18	NDC:51414-400-18	2 in 1 PACKAGE	01/06/2018
18		3 g in 1 POUCH; Type 0: Not a Combination Product
19	NDC:51414-400-19	3 in 1 PACKAGE	01/06/2018
19		3 g in 1 POUCH; Type 0: Not a Combination Product
20	NDC:51414-400-20	4 in 1 PACKAGE	01/06/2018
20		3 g in 1 POUCH; Type 0: Not a Combination Product
21	NDC:51414-400-21	5 in 1 PACKAGE	01/06/2018
21		3 g in 1 POUCH; Type 0: Not a Combination Product
22	NDC:51414-400-22	10 in 1 PACKAGE	01/06/2018
22		4 g in 1 POUCH; Type 0: Not a Combination Product
23	NDC:51414-400-23	15 in 1 PACKAGE	01/06/2018
23		4 g in 1 POUCH; Type 0: Not a Combination Product
24	NDC:51414-400-24	20 in 1 PACKAGE	01/06/2018
24		4 g in 1 POUCH; Type 0: Not a Combination Product
25	NDC:51414-400-25	25 in 1 PACKAGE	01/06/2018
25		4 g in 1 POUCH; Type 0: Not a Combination Product
26	NDC:51414-400-26	30 in 1 PACKAGE	01/06/2018
26		4 g in 1 POUCH; Type 0: Not a Combination Product
27	NDC:51414-400-27	35 in 1 PACKAGE	01/06/2018
27		4 g in 1 POUCH; Type 0: Not a Combination Product
28	NDC:51414-400-28	40 in 1 PACKAGE	01/06/2018
28		4 g in 1 POUCH; Type 0: Not a Combination Product
29	NDC:51414-400-29	45 in 1 PACKAGE	01/06/2018
29		4 g in 1 POUCH; Type 0: Not a Combination Product
30	NDC:51414-400-30	50 in 1 PACKAGE	01/06/2018
30		4 g in 1 POUCH; Type 0: Not a Combination Product
31	NDC:51414-400-31	55 in 1 PACKAGE	01/06/2018
31		4 g in 1 POUCH; Type 0: Not a Combination Product
32	NDC:51414-400-32	60 in 1 PACKAGE	01/06/2018
32		4 g in 1 POUCH; Type 0: Not a Combination Product
33	NDC:51414-400-33	65 in 1 PACKAGE	01/06/2018
33		4 g in 1 POUCH; Type 0: Not a Combination Product
34	NDC:51414-400-35	75 in 1 PACKAGE	01/06/2018
34		4 g in 1 POUCH; Type 0: Not a Combination Product
35	NDC:51414-400-36	80 in 1 PACKAGE	01/06/2018
35		4 g in 1 POUCH; Type 0: Not a Combination Product
36	NDC:51414-400-37	85 in 1 PACKAGE	01/06/2018
36		4 g in 1 POUCH; Type 0: Not a Combination Product
37	NDC:51414-400-38	90 in 1 PACKAGE	01/06/2018
37		4 g in 1 POUCH; Type 0: Not a Combination Product
38	NDC:51414-400-39	95 in 1 PACKAGE	01/06/2018
38		4 g in 1 POUCH; Type 0: Not a Combination Product
39	NDC:51414-400-40	100 in 1 PACKAGE	01/06/2018
39		4 g in 1 POUCH; Type 0: Not a Combination Product
40	NDC:51414-400-34	70 in 1 PACKAGE	01/06/2018
40		4 g in 1 POUCH; Type 0: Not a Combination Product
41	NDC:51414-400-41	16 in 1 BOTTLE	01/06/2018
41		3 g in 1 POUCH; Type 0: Not a Combination Product
42	NDC:51414-400-42	60 in 1 BOTTLE	01/06/2018
42		3 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/08/2012

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-400)

Revised: 12/2022

Document Id: f0036d99-1937-1b61-e053-2995a90aaff8

Set id: cbc11bca-9550-49e0-9401-cef535c5535d

Version: 5

Effective Time: 20221217

Yuyao Jessie Commodity Co.,Ltd.