family wellness pain scar itch

Generic: bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl

Labeler: trifecta pharmaceutical usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name family wellness pain scar itch
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl
Labeler trifecta pharmaceutical usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [USP'U]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Trifecta Pharmaceutical USA LLC

Identifiers & Regulatory

Product NDC 69396-054
Product ID 69396-054_298daa67-7d1e-40a2-e063-6294a90a1933
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2019-08-30

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396054
Hyphenated Format 69396-054

Supplemental Identifiers

RxCUI
1359350
UPC
0032251533143
UNII
89Y4M234ES 057Y626693 19371312D4 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name family wellness pain scar itch (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-054-01) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (4)

bacitracin zinc (500 [USP'U]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "298daa67-7d1e-40a2-e063-6294a90a1933", "openfda": {"upc": ["0032251533143"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["9e507ec5-310d-3a21-e053-2a95a90a15a6"], "manufacturer_name": ["Trifecta Pharmaceutical USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-054-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-054-01", "marketing_start_date": "20190922"}], "brand_name": "Family Wellness Pain Scar Itch", "product_id": "69396-054_298daa67-7d1e-40a2-e063-6294a90a1933", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-054", "generic_name": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B, Pramoxine HCL", "labeler_name": "Trifecta Pharmaceutical USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Family Wellness Pain Scar Itch", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190830", "listing_expiration_date": "20261231"}