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
11 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:52454-001-021 in 1 BOX01/01/2018
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:52454-001-0325 in 1 BOX01/01/2018
31 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: 6/2023
Document Id: ff3b8c57-c65e-7c3f-e053-6394a90a937e
Set id: 74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
Version: 8
Effective Time: 20230628
 
Zhejiang Fonow Medicine Co., Ltd.