SANITIZING WIPES- benzalkonium chloride cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Jurong Dongfa General Merchandise Co Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Recommended for repeated use. ●Dries in seconds.
Authorization status:
OTC monograph not final
Authorization number:
75127-101-01, 75127-101-02, 75127-101-03

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SANITIZING WIPES- benzalkonium chloride cloth

Jurong Dongfa General Merchandise 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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75127-101 SANITIZING ALCOHOL FREE WIPES 0.13% Benzalkonium chloride

Active Ingredient

Benzalkonium Chloride 0.13%

Purpos e

Antiseptic

USE

For hand sanitizing to decrease bacteria on the skin.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Warning

For external use only

May irritate eyes

Keep out of reach of children unless under adult supervision.

Directions

.Tear V notch on top of plastic bag.

. Pull first wipe from the center of roll up through opening of bag. Thread first wipe through the

dispensing nozzle in lid of floor stand or dispenser.

- Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be

mounted with wipes dispensing up.

Inactive ingredients

Water (Aqua),Propylene Glycol,Polysorbate 20,Disodium

Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate,Aloe Barbadensis Leaf

Juice,TocopheryI Acetate (Vitamin E), Fragrance.

SANITIZING WIPES

benzalkonium chloride cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:75127-10 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

Jurong Dongfa General Merchandise Co Ltd

DISO DIUM CO CO AMPHO DIACETATE (UNII: 18 L9 G3U51M)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:75127-10 1-

4 in 1 CARTON

12/10 /20 20

1

8 0 0 in 1 BAG

1

4 g in 1 NOT APPLICABLE; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:75127-10 1-

12 in 1 CARTON

12/10 /20 20

2

50 in 1 PAIL

2

4 g in 1 NOT APPLICABLE; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:75127-10 1-

2 in 1 CARTON

12/10 /20 20

3

8 0 0 in 1 BAG

3

4 g in 1 NOT APPLICABLE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/10 /20 20

Labeler -

Jurong Dongfa General Merchandise Co Ltd (528077612)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Juro ng Do ngfa General Merchandise Co Ltd

528 0 776 12

ma nufa c ture (75127-10 1)

Revised: 2/2021

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