PBZ ™ OTC Cream

Manufacturer
Kingsway Pharmaceuticals dba NFI, LLC
Effective date
2025-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:31

Label at a glance#

ProductPBZ OTC
Active ingredientTRIPELENNAMINE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a physician. Storage Information: Protect from freezing and excessive heat, store at 68°-77°F (20°-25°C).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tripelennamine HCL 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching associated with:

  • insect bites
  • minor burns
  • minor cuts
  • minor skin irritations
  • scrapes
  • sunburn
  • rashes due to poison ivy, poison oak, or poison sumac

Warnings

WARNINGS SECTION

For external use only.
Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not use

OTC - DO NOT USE SECTION

if packaging is damaged or opened.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a physician.
Storage Information: Protect from freezing and excessive heat, store at 68°-77°F (20°-25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/Acrylamide Copolymer, Allantoin, Aloe Barbadensis Leaf Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, dl-Alpha Tocopheryl Acetate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Panthenol, PEG 100 Stearate, Phenoxyethanol, Polysorbate 80, Polysorbate 85, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water
 

SPL UNCLASSIFIED SECTION

MANUFACTURED IN THE USA
Distributed By:
Kingsway Pharmaceuticals dba NFI Consumer Products
636 Shelby Street, Suite 300, Bristol, TN 37620
800-432-9334

PRINCIPAL DISPLAY PANEL – CARTON LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR THE ENTRIE FAMILY

pbz™
OTC
Pyribenzamine™

NOW AVAILABLE OTC

POWERFUL
ITCH RELIEF

ANTIHISTAMINE CREAM
AGES 2+ YRS

  • Insect Bites
  • Minor Burns, Cuts, Scrapes
  • Minor Skin Irritations
  • Poison Ivy, Oak, & Sumac
  • Sunburn

 
ITCH
 
Net WT 1 OZ. (28g)

image-01image-01
 

PRINCIPAL DISPLAY PANEL – POUCH LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR THE ENTRIE FAMILY
 
pbz™
OTC
Pyribenzamine™
 
ITCH
NET WT 3.25g (0.115oz)
 
VOTED
PRODUCT
of
THE YEAR

Consumer Survey of
Product Innovation
2025

*WINNER IN IMMEDIATE RELIEF CATEGORY
2025 PRODUCT OF THE YEAR AWARD, CHOSEN BY
A KANTAR SURVEY OF 40,000 PEOPLE
 
ANTIHISTAMINE CREAM
SAMPLE, NOT FOR RESALE

image-02
image-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2711712tripelennamine HCl 1 % Topical CreamPSN3
2711712tripelennamine hydrochloride 10 MG/ML Topical CreamSCD3
2711712tripelennamine hydrochloride 1 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69993-151-01PBZ OTC1 in 1 CARTONCREAM13
69993-151-01PBZ OTC28 g in 1 TUBECREAM283
69993-151-02PBZ OTC3.25 g in 1 POUCHCREAM3.253

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69993-15169993-151-01, 69993-151-02
75587-151

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
ndc (package): 69993-151-02
ndc (package): 69993-151-01
ndc (product): 69993-151
ndc11 (package): 69993015102
ndc11 (package): 69993015101
spl id: d144cc3d-1fca-4a3e-932c-7ca07b85068b
spl set id: 12f72d74-018f-4bc6-acd4-175ca3af4c6d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.