Arthritis Pain Reliever
FDA Label NDC 59092-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hpi Health Products Inc. for the product Arthritis Pain Reliever (NDC 59092-001). 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, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

distributed by:
Natural Pain Relief Agency Inc.
Phoenix, AZ 85086

Active Ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

  • For external use only.

Otc - When Using

When using this product

  • use only as directed
  • do not bandage
  • do not use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation occurs upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use
  • do not expose the area treated with product to heat or direct sunlight
  • do not use if you are allergic to capsaicin or chili peppers

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • redness if present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
  • Children 18 years and younger: ask a doctor

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

Abies balsamea, carbomer, cedarwood bark oil, diazolidinyl urea, ethanol, methylparaben, propylene glycol, propylparaben, triethanolamine, water

Questions Or Comments?

Call us toll-free at (877) 514-3132 between 9am and 4pm (PST), Monday through Friday. Visit us on the website at lakotaherbs.com

Principal Display Panel - 88 Ml Bottle Carton

LaKOTA
Roll-On Pain Reliever

Arthritis Pain Releiver

Capsaicin – Topical analgesic

3 fl.oz/88ml

Principal Display Panel (88 ml Bottle Carton)

Principal Display Panel (88 ml Bottle Carton)

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