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

Full FDA labeling including 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 other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

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

Active Ingredient

Capsaicin 0.1%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

For external use only

When Using This Product

  • If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use immediately and read inside carton for important Information
  • do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics
  • use only as directed. Read and follow all directions and warnings on this carton
  • do not use if you are allergic to capsaicin or chili peppers

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

Directions

adults and children over 18 years:

  • apply to affected area
  • massage into painful area until thoroughly absorbed
  • repeat if necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    • children 18 years or younger: ask a doctor

Storage And Handling

  • store at 15°-25°C (59°-77°F)

Inactive Ingredients

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

Questions: Or Comments

1-800-697-3329

Principal Display Panel - 56.6 G Tube Carton

Nationwide
Pharmaceutical

• Deep Penetrating • Odor Free

CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM
High Potency

CAPSAICIN HP

ARTHRITIS PAIN RELIEF

NET WT 2.0 oz (56.6 g)

Principal Display Panel (56.6 g Tube Carton)

Principal Display Panel (56.6 g Tube Carton)

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