Pbz™

Pbz™
SPL v3
SPL
SPL Set ID 12f72d74-018f-4bc6-acd4-175ca3af4c6d
Route
TOPICAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tripelennamine (1 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Tripelennamine HCL 1%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Tripelennamine HCL 1%

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
Section 42229-5

MANUFACTURED IN THE USA

Distributed By:

Kingsway Pharmaceuticals dba NFI Consumer Products

636 Shelby Street, Suite 300, Bristol, TN 37620

800-432-9334

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.

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).

Do Not Use

if packaging is damaged or opened.

Active Ingredient

Tripelennamine HCL 1%

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

 

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.

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

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)



 


Structured Label Content

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
Section 42229-5 (42229-5)

MANUFACTURED IN THE USA

Distributed By:

Kingsway Pharmaceuticals dba NFI Consumer Products

636 Shelby Street, Suite 300, Bristol, TN 37620

800-432-9334

Purpose

Topical Analgesic

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.

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).

Do Not Use (Do not use)

if packaging is damaged or opened.

Active Ingredient

Tripelennamine HCL 1%

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

 

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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

Principal Display Panel – Pouch Label (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

Principal Display Panel – Carton Label (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)



 


Advanced Ingredient Data


Raw Label Data

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