Capsaicin Hp Arthritis Pain Relief Cream
FDA Label NDC 69375-006

13 label sections · Submitted to the FDA by Nationwide Pharmaceutical Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nationwide Pharmaceutical Llc for the product Capsaicin Hp Arthritis Pain Relief (NDC 69375-006). 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, uses, warnings, do not, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin 0.1%

Purpose

Topical analgesic

Uses

For relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do Not

  • apply to wounds or damaged skin
  • use with a heating pad
  • use if you are allergic to capsicum or chili peppers.

When Using This Product

  • read insert inside of carton before using
  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
  • a transient burning sensation may occur upon application but generally disappears in several days
  • do not expose the treated area to heat or direct sunlight

    • 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 doctor.

Stop Use And Ask A Doctor If

  • redness is present or irritation develops
  • severe burning sensation occurs

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Drug Facts (continued)

Directions

Adults and children over 18 years:

  • use only as directed
  • apply to affected area not more than 3 to 4 times daily
  • massage into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • wash hands with soap and water after applying

    • Children 18 years or younger: Do not use, consult a doctor

    Other Information store at room temperature 15°-25°C (59°-77°F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-40 stearate, petroleum jelly, sorbitol, water

Questions:

or comments 1-800-697-3329

Principal Display Panel - 56.6 G Tube Carton

CAPSAICIN HP

ARTHRITIS PAIN RELIEF

CLOSE CAP TIGHTLY AFTER USE, KEEP CARTON AS IT CONTAINS IMPORTANT IMFORMATION.

†† This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Capzasin HP®

Manufactured for and Distributed by:
Nationwide Pharmaceutical
San Antonio, TX, 78216

Nationwide
Pharmaceutical

• Deep Penetrating • Odor Free

NDC# 69375-006-60

CAPSAICIN HP
High Potency

CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

ARTHRITIS PAIN RELIEF

Compare to the
active ingredient
in Capzasin HP®††

NET WT 2.0 oz (56.6 g)

Nationwidepharmaceutical• Deep Penetrating • Odor Freendc# 69375-006-60capsaicin Hphigh Potencycapsaicin 0.1% / Topical Analgesic Creamarthritis Pain Reliefcompare To Theactive Ingredientin Capzasin Hp®††net Wt 2.0 Oz (56.6 G) (Capsaicin Cream 01)

Nationwidepharmaceutical• Deep Penetrating • Odor Freendc# 69375-006-60capsaicin Hphigh Potencycapsaicin 0.1% / Topical Analgesic Creamarthritis Pain Reliefcompare To Theactive Ingredientin Capzasin Hp®††net Wt 2.0 Oz (56.6 G) (Capsaicin Cream 01)

* Please review the disclaimer below.