Label: TRIPLE ANTIBIOTIC OINTMENT - bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
- NDC Code(s): 51141-0070-1, 51141-0070-3, 51141-0070-5
- Packager: NeoPharm Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 25, 2010
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- Active ingredient
Bacitracin Zinc 400 units
Neomycin Sulfate 3.5mg
Polymyxin B Sulfate 5,000 unitsClose
First aid antibiotic
First aid antibiotic
First aid antibioticClose
First aid to help prevent infection in minor:
For external use only
Do not use if you are allergic to any of the ingredients
Stop use and ask a doctor if
- you need to use more than 1 week
- condition persists or gets worse
- symptoms persist for more than 1 week or clear up and occur again within a few days.
- rash or other allergic reaction develops
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- adults and children 2 years of age or older:
- clean the affected area
- apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
- may be covered with a sterile bandage
- children under 2 years of age: ask a doctor
- Other information
store at 59° to 77°F
- Inactive ingredients
Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatumClose
- Package label panel
Triple Antibiotic OintmentClose
- INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC OINTMENT
bacitracin zinc, neomycin sulfate, polymyxin b ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0070 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARETH-2 (UNII: V56DFE46J5) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51141-0070-1 1 in 1 BOX 1 28 g in 1 TUBE 2 NDC:51141-0070-5 1 in 1 BOX 2 14 g in 1 TUBE 3 NDC:51141-0070-3 1 in 1 BOX 3 9.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/01/2010 Labeler - NeoPharm Co., Ltd (631101883) Registrant - NeoPharm Co., Ltd (631101883) Establishment Name Address ID/FEI Business Operations NeoPharm Co., Ltd 631101883 manufacture