PBZ OTC by IBR Packaging, LLC PBZ™ OTC Cream

PBZ OTC by

Drug Labeling and Warnings

PBZ OTC by is a Otc medication manufactured, distributed, or labeled by IBR Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PBZ OTC- tripelennamine hcl 1% cream 
IBR Packaging, LLC

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PBZ™ OTC Cream

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
 

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

PBZ OTC 
tripelennamine hcl 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75587-151(NDC: 69993-151)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPELENNAMINE (UNII: 3C5ORO99TY) (TRIPELENNAMINE - UNII:3C5ORO99TY)	TRIPELENNAMINE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 85 (UNII: A7F3N56197)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75587-151-02	3.25 g in 1 POUCH; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2025

Labeler - IBR Packaging, LLC (081060205)

Revised: 4/2025

Document Id: a709a20b-c816-41be-afb9-b487e339dc43

34390-5

Set id: a709a20b-c816-41be-afb9-b487e339dc43

Version: 1

Effective Time: 20250410