Pbz Otc Cream
FDA Label NDC 69993-151

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Pharmaceuticals Dba Nfi, Llc for the product Pbz Otc (NDC 69993-151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, if pregnant or breast-feeding,, keep out of reach of children and pets., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
 

Other

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)

    Image-01 (Lidocaine 01)

    Image-01 (Lidocaine 01)

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