EXTRA STRENGTH PAIN RELIEVER- capsaicin and menthol, unspecified form cream

Extra Strength Pain Reliever by

Drug Labeling and Warnings

Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by HPI Health Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
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

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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)

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
capsaicin and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59092-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM)	capsaicin	0.35 mg  in 1 mL
menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A)	menthol, unspecified form	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
carbomer interpolymer type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
alcohol (UNII: 3K9958V90M)
diazolidinyl urea (UNII: H5RIZ3MPW4)
trolamine (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59092-002-01	1 in 1 BOX
1		57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2014

Labeler - HPI Health Products Inc. (202932864)