ALCOHOL DISINFECTANT WIPES cloth

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA), PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3), PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T)
Available from:
Zhejiang Huanghua Biological Technology Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
1.Open cover and remove seal. 2.Pull out wipe corner from center of the roll. 3.Thread through hole in the cover. 4.Close lid after use to retain moisture. For children less than 2 months of age. On open skin wounds. Disinfection Sterilization No Rinseing
Authorization status:
OTC monograph not final
Authorization number:
41546-018-01

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ALCOHOL DISINFECTANT WIPES- alcohol disinfectant wipes cloth

Zhejiang Huanghua Biological Technology 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.

----------

store between 15-30°C(59-86°F)

avoid freezing and excessive heat above 40°C(104°F)

pure water

1.Open cover and remove seal.

2.Pull out wipe corner from center of the roll.

3.Thread through hole in the cover.

4.Close lid after use to retain moisture.

alcohol

Benzalkamine

2-methyl-4-isothiazoline-3-one

propylene glyco

2-phenoxyethanol

For children less than 2 months of age.

On open skin wounds.

keep out of reach of children

Disinfection

Sterilization

No Rinseing

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

ALCOHOL DISINFECTANT WIPES

alcohol disinfectant wipes cloth

Product Information

Zhejiang Huanghua Biological Technology Co., Ltd

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41546 -0 18

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

315 mL

in 8 0

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

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

7.4 g

in 8 0

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA) (METHYLISOTHIAZOLINONE -

UNII:229 D0 E1QFA)

METHYLISOTHIAZOLINONE

7.4 g

in 8 0

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

UNII:6 DC9 Q16 7V3)

PROPYLENE GLYCOL

7.4 g

in 8 0

PHENO XYETHANO L (UNII: HIE49 2ZZ3T) (PHENOXYETHANOL - UNII:HIE49 2ZZ3T)

PHENOXYETHANOL

7.4 g

in 8 0

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41546 -0 18 -0 1

8 0 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

11/25/20 20

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 rt333E

11/25/20 20

Labeler -

Zhejiang Huanghua Biological T echnology Co., Ltd (415467459)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Zhejiang Huanghua Bio lo gical Techno lo gy Co ., Ltd

41546 7459

ma nufa c ture (41546 -0 18 )

Revised: 12/2020

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