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.
PBZ ™ OTC Cream
- Manufacturer
- IBR Packaging, LLC
- Effective date
- 2025-04-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:39:46
Label at a glance#
ProductPBZ OTC
Active ingredientTRIPELENNAMINE
Label structure9 sections
Storage and handling
Protect from freezing and excessive heat, store at 68 o – 77 o F (20 o – 25 o C).
Label contents#
Full prescribing information#
Active Ingredient:
Tripelennamine HCL 1%
Purpose:
Topical Analgesic
Use:
Temporarily relieves pain and itching associated with:
- insect bites
- minor burns and minor cuts
- minor skin irritations
- scrapes
- sunburn
- rashes due to poison ivy, poison oak, or poison sumac
Warnings:
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
if packaging is damaged or opened.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact Poison Control Center right away.
Directions:
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 68o – 77oF (20o – 25oC).
Inactive Ingredients:
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
Distributed By:
Kingsway Pharmaceuticals dba NFI Consumer Products
636 Shelby Street, Suite 300, Bristol, TN 37620
Made in the U.S.A.
PRINCIPAL DISPLAY PANEL – Pouch Label
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
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- PBZ OTC
- Tripelennamine HCl 1%
- TRIPELENNAMINE
- ALLANTOIN
- ALOE VERA LEAF
- MEDIUM-CHAIN TRIGLYCERIDES
- CETYL ALCOHOL
- DIMETHICONE, UNSPECIFIED
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- GLYCERYL MONOSTEARATE
- MINERAL OIL
- PANTHENOL
- PEG-100 MONOSTEARATE
- PHENOXYETHANOL
- POLYSORBATE 80
- POLYSORBATE 85
- SODIUM POLYACRYLATE (8000 MW)
- STEARIC ACID
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75587-151 | 75587-151-02 |
| 69993-151 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PBZ OTC | TRIPELENNAMINE HCL 1% | Kingsway Pharmaceuticals dba NFI, LLC | 12f72d74-018f-4bc6-acd4-175ca3af4c6d | 2025-08-29 | Warnings | 69993-151 |
| a709a20b-c816-41be-afb9-b487e339dc43 | a709a20b-c816-41be-afb9-b487e339dc43 | 2025-04-10 | Warnings | a709a20b-c816-41be-afb9-b487e339dc43 a709a20b-c816-41be-afb9-b487e339dc43 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.