Label: FONOW- bacitracin, neomycin, polymyxin b, lidocaine hcl ointment
- NDC Code(s): 52454-001-01, 52454-001-02, 52454-001-03, 52454-001-04
- Packager: Zhejiang Fonow Medicine Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 21, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each gram)
- Purpose
- Uses
- Directions
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Warnings
For external use only.
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
- the condition persists or gets worse
- a rash or other allergic reaction occurs
- Keep out of reach of children
- Other information
- Inactive ingredient
-
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........................ .... .... ... .......................... AnestheticUses
First aid to help prevent infection and provide temporary relief of pain in minor cuts scrapes burns
Warnings
For external use only.
Do not use- in the eyes
- over large ares of the body
- if allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Ask a doctor before use if you have- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if- condition persists or gets worse
- 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
Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 or 3 times daily. May be covered with a sterile bandage.
Other informationStore at temperature 50°-86℉(10°-30℃)
Inactive ingredientWhite Petrolatum
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INGREDIENTS AND APPEARANCE
FONOW
bacitracin, neomycin, polymyxin b, lidocaine hcl ointmentProduct 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 WHITE PETROLATUM (UNII: B6E5W8RQJ4) 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 3 NDC:52454-001-03 25 in 1 BOX 01/01/2018 3 1 g in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52454-001-04 1 g in 1 POUCH; Type 0: Not a Combination Product 12/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M004 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)