FIRST AID ONLY TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment 
Acme united Corporation

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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First Aid Only Triple Antibiotic Ointment

Active ingredients

Bacitracin zinc 400 units

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Polymyxin B sulfate 5000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor •cuts •scrapes •burns

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 •on deep lacerations or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if •condition persists or gets worse, •a rash or allergic reaction occurs, •the condition persists for more than 7 days

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

Adults and Children Clean the affected area, apply a small amount of this product

(equal to the surface area of a fingertip) 1 to 3 times daily.

Other information

Store at room temperature.

Inactive ingredient

petrolatum

Questions or comments?

Questions 1.800.835.2263

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FIRST AID ONLY TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN417.8 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5322.8 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5605-07144 in 1 BOX, UNIT-DOSE11/12/2019
10.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5605-0525 in 1 BOX, UNIT-DOSE11/12/2019
20.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5605-0660 in 1 CARTON11/12/2019
30.5 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0924-5605-0412 in 1 CARTON11/12/2019
40.5 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:0924-5605-0310 in 1 CARTON11/12/2019
50.5 g in 1 PACKET; Type 0: Not a Combination Product
6NDC:0924-5605-010.5 g in 1 PACKET; Type 0: Not a Combination Product11/12/2019
7NDC:0924-5605-026 in 1 BAG11/12/2019
70.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B11/12/2019
Labeler - Acme united Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5605) , repack(0924-5605)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5605) , repack(0924-5605)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0924-5605)

Revised: 11/2019
Document Id: 972c8d85-4d55-95e3-e053-2a95a90a4cd5
Set id: 972cabf7-cdce-67ce-e053-2a95a90af92f
Version: 1
Effective Time: 20191112
 
Acme united Corporation