FDA Label for Pbz Otc
View Indications, Usage & Precautions
Pbz Otc Product Label
The following document was submitted to the FDA by the labeler of this product Kingsway Pharmaceuticals Dba Nfi, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
* Please review the disclaimer below.
