FDA Label for Capsaicin Hp Arthritis Pain Relief

View Indications, Usage & Precautions

Capsaicin Hp Arthritis Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Nationwide Pharmaceutical 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.

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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)


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