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Extra Strength Pain Reliever by HPI Health Products Inc.

Medically reviewed on Oct 30, 2017

Dosage form: cream
Ingredients: capsaicin 0.35mg in 1mL, menthol, unspecified form 30mg in 1mL
Labeler: HPI Health Products Inc.
NDC Code: 59092-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Extra Strength Pain Reliever

Drug Facts

Active IngredientPurpose
Capsaicin 0.035%Topical analgesic
Menthol 3%Topical analgesic

Uses

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

  • simple backache
  • arthritis
  • bruises
  • strains
  • sprains

Warnings
  • For external use only.

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 may occur 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

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

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

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

carbomer, ethyl alcohol, germaben II, 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 web at lakotaherbs.com

Manufactured exclusively for
and distributed by:
Natural Pain Relief Agency Inc.
Phoenix, AZ 85086

PRINCIPAL DISPLAY PANEL - 57 mL Bottle Box

LaKOTA®

SOFT-TOUCH PAIN RELIEVER

Extra Strength
Pain Reliever

Capsaicin and Menthol -
Topical analgesic

57mL (2 fl oz)

EXTRA STRENGTH PAIN RELIEVER 
capsaicin and menthol, unspecified form cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59092-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
capsaicin (capsaicin) capsaicin0.35 mg  in 1 mL
menthol, unspecified form (menthol, unspecified form) menthol, unspecified form30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
carbomer interpolymer type A (allyl sucrose crosslinked) 
alcohol 
diazolidinyl urea 
trolamine 
water 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59092-002-011 BOTTLE, WITH APPLICATOR in 1 BOX
157 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2014
Labeler - HPI Health Products Inc. (202932864)

 
HPI Health Products Inc.

← See all Extra Strength Pain Reliever brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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