ANTIBACTERIAL WET WIPES- benzalkonium chloride swab
SHAOXING BAIXUN HYGIENE PRODUCTS 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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70888-001 Antibacterial Wet Wipes

Active ingredient

benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

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

WATER PROPYLENE GLYCOL OCTHILINONE .ALPHA.-TOCOPHEROL

ANTIBACTERIAL WET WIPES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70888-001
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)
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70888-001-01	15 in 1 PACKAGE	08/06/2016
1		0.06 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70888-001-02	30 in 1 BOTTLE	08/06/2016
2		0.035 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:70888-001-03	10 in 1 PACKAGE	08/06/2016
3		0.042 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:70888-001-04	30 in 1 PACKAGE	08/06/2016
4		0.126 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:70888-001-05	50 in 1 PACKAGE	08/06/2016
5		0.21 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC:70888-001-06	80 in 1 PACKAGE	08/06/2016
6		0.336 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC:70888-001-07	100 in 1 PACKAGE	08/06/2016
7		0.42 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC:70888-001-08	50 in 1 BOTTLE	08/06/2016
8		0.21 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC:70888-001-09	80 in 1 BOTTLE	08/06/2016
9		0.336 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC:70888-001-10	100 in 1 BOTTLE	08/06/2016
10		0.42 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	08/06/2015	09/06/2023

Labeler - SHAOXING BAIXUN HYGIENE PRODUCTS CO.,LTD (544419193)

Name	Address	ID/FEI	Business Operations
Establishment
SHAOXING BAIXUN HYGIENE PRODUCTS CO.,LTD		544419193	manufacture(70888-001)

Revised: 9/2023

Document Id: 04be557f-75b0-7046-e063-6394a90aa5e6

Set id: 396303b6-3880-25b7-e054-00144ff88e88

Version: 5

Effective Time: 20230907

SHAOXING BAIXUN HYGIENE PRODUCTS CO.,LTD