TRIPLE ANTIOBIOTIC- triple antibiotic ointment ointment 
Davemed Healthcare 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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Triple Antiobiotic

DIRECTIONS

USES

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

If ingested contact a poison control center right away.

NEOMYCIN

BACITRACIN

PRAMOXINE HCI

Petrolatum

First Aid Antibiotic. For temporary relief of pain associated with minor burns.

label

TRIPLE ANTIOBIOTIC 
triple antibiotic ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70897-003-010.9 g in 1 PACKET; Type 0: Not a Combination Product08/11/2016
2NDC:70897-003-0214.2 g in 1 TUBE; Type 0: Not a Combination Product08/11/2016
3NDC:70897-003-0328.4 g in 1 TUBE; Type 0: Not a Combination Product08/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/11/2016
Labeler - Davemed Healthcare Co., Ltd. (529128716)
Establishment
NameAddressID/FEIBusiness Operations
Davemed Healthcare Co., Ltd.529128716manufacture(70897-003)

Revised: 2/2019
Document Id: 80d77b64-4575-2679-e053-2991aa0aa045
Set id: 39d34a43-a672-6e9c-e054-00144ff8d46c
Version: 2
Effective Time: 20190201
 
Davemed Healthcare Co., Ltd.