HAND SANITIZER WIPES- benzalkonium chloride gel
Hangzhou Linkeweier Daily Chemicals 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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Hand Sanitizing Wipes

Active Ingredient

benzalkonium chloride 0.13%

Purpose

Antimicrobial

Use

for hand sanitizing to decrease bacteria on the skin.

recommended for repeated use

Warning

For external use only

when using this product,avoid contact with eyes,

In case of contact flush eyes with water

Stop use and ask a doctor if irritation or redness develop

if swallowed get medical help or caontact a poison control center reght away.

Keep out of reach of children

Directions

take wipe and rub thoroughly over all surfaces of both hands.rub hands together briskly to dry ,dispose of wipe

INACTIVE INGREDIENT

purified Water,Glycerin,Aloe Barbadensis Leaf Juice,nonionic surfactant

HAND SANITIZER WIPES
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71766-001
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71766-001-01	1000 in 1 CARTON	10/10/2017
1		1 in 1 PACKET
1		0.016 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:71766-001-02	120 in 1 CARTON	10/10/2017
2		10 in 1 PACKET
2		0.016 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:71766-001-03	120 in 1 CARTON	10/10/2017
3		15 in 1 PACKET
3		0.024 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:71766-001-04	36 in 1 CARTON	10/10/2017
4		25 in 1 PACKET
4		0.04 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:71766-001-05	24 in 1 CARTON	10/10/2017
5		50 in 1 PACKET
5		0.008 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC:71766-001-06	24 in 1 CARTON	10/10/2017
6		80 in 1 PACKET
6		0.128 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC:71766-001-07	24 in 1 CARTON	10/10/2017
7		100 in 1 PACKET
7		0.16 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC:71766-001-08	4 in 1 CARTON	10/10/2017
8		800 in 1 PACKET
8		1.28 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC:71766-001-09	4 in 1 CARTON	10/10/2017
9		1200 in 1 PACKET
9		1.92 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC:71766-001-10	12 in 1 CARTON	10/10/2017
10		250 in 1 PACKET
10		0.4 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	10/10/2017

Labeler - Hangzhou Linkeweier Daily Chemicals Co., Ltd. (544544821)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Linkeweier Daily Chemicals Co., Ltd.		544544821	manufacture(71766-001)