FONOW- bacitracin, neomycin, polymyxin b, lidocaine hcl ointment

Fonow by

Drug Labeling and Warnings

Fonow by is a Otc medication manufactured, distributed, or labeled by Zhejiang Fonow Medicine Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INDICATIONS & USAGE

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

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

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

INGREDIENTS AND APPEARANCE

FONOW 
bacitracin, neomycin, polymyxin b, lidocaine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52454-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)	945 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52454-001-01	100 in 1 BOX	01/01/2018
1		1 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52454-001-02	1 in 1 BOX	01/01/2018
2		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/01/2018

Labeler - Zhejiang Fonow Medicine Co., Ltd (420094818)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Fonow Medicine Co., Ltd		420094818	manufacture(52454-001)