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详细信息

FONOW- bacitracin, neomycin, polymyxin b, lidocaine hcl ointment 
Zhejiang Fonow Medicine 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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FONOW Triple Antibiotic Ointment With Pain Relief


FONOW
Triple Antibiotic Ointment
With Pain Relief


Active ingredients (in each gram)

Bacitracin 500 units

Neomycin 3.5mg

Polymyxin B 5000 units

Lidocaine HCL 40 mg


Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Anesthetic


Uses Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns


Warnings

For external use only.


Do not use

if allergic to any of the ingredients
in or near the eyes
over large areas of the body


Stop use and ask a doctor if
condition lasts or gets worse
symptoms last for more than 7 days or clear up and come back within a few days
a rash or other allergic reaction occurs


Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.


Directions

Adults and children 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage
Children under 2: ask a doctor


Inactive ingredient

White Petrolatum


PRINCIPAL DISPLAY PANEL

Drug Facts

Active ingredients (in each gram) Purpose

Bacitracin 500 units .....................................................First aid antibiotic

Neomycin 3.5mg ............................................................First aid antibiotic

Polymyxin B 5000 units..................................................First aid antibiotic

Lidocaine Hcl 40 mg........................ .... .... ... ........................ Anesthetic


Uses Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns


Warnings

For external use only.

Do not use

if allergic to any of the ingredients

in or near the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

condition lasts or gets worse

symptoms last for more than 7 days or clear up and come back within a few days

a rash or other allergic reaction occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage

Children under 2: ask a doctor

Other information Store at temperature 50°-86℉(10°-30℃)

Inactive ingredient White Petrolatum

52454-00-01-pouch-box-100 label52545-001-02-tube-box label52454-001-03-pouch-box-25 label

FONOW 
bacitracin, neomycin, polymyxin b, lidocaine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52454-001
Route of AdministrationTOPICAL

Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)BACITRACIN500 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)POLYMYXIN B5000 [iU]  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)945 mg  in 1 g

Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52454-001-01100 in 1 BOX01/01/2018
1
1 g in 1 POUCH; Type 0: Not a Combination Product

2NDC:52454-001-021 in 1 BOX01/01/2018
2
15 g in 1 TUBE; Type 0: Not a Combination Product

3NDC:52454-001-0325 in 1 BOX01/01/2018
3
1 g in 1 POUCH; Type 0: Not a Combination Product


Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2018
Labeler - Zhejiang Fonow Medicine Co., Ltd. (420094818)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Fonow Medicine Co., Ltd.
420094818manufacture(52454-001)


Revised: 4/2021

 

Zhejiang Fonow Medicine Co., Ltd.


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