PBZ OTC- tripelennamine hcl 1% cream

PBZ OTC by

Drug Labeling and Warnings

PBZ OTC by is a Otc medication manufactured, distributed, or labeled by Kingsway Pharmaceuticals dba NFI, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tripelennamine HCL 1%

Purpose

Topical Analgesic

Use

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

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 68°-77°F (20°-25°C).

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

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

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)

INGREDIENTS AND APPEARANCE

PBZ OTC 
tripelennamine hcl 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 69993-151-01	1 in 1 CARTON	02/01/2025
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2025

Labeler - Kingsway Pharmaceuticals dba NFI, LLC (121681919)