Extra Strength Pain Reliever (Capsaicin And Menthol, Unspecified Form) Cream [Hpi Health Products Inc.] -

EXTRA STRENGTH PAIN RELIEVER (CAPSAICIN AND MENTHOL, UNSPECIFIED FORM) CREAM [HPI HEALTH PRODUCTS INC.]
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NDC	59092-002-01
Set ID	d742afa6-2cba-47ec-bc9b-a09d938b318f
Category	HUMAN OTC DRUG LABEL
Packager	HPI Health Products Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

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
SPL UNCLASSIFIED SECTION

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)

Active Ingredient	Purpose
Capsaicin 0.035%	Topical analgesic
Menthol 3%	Topical analgesic

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - HPI Health Products Inc. (202932864)

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Medic

EXTRA STRENGTH PAIN RELIEVER (CAPSAICIN AND MENTHOL, UNSPECIFIED FORM) CREAM [HPI HEALTH PRODUCTS INC.]

When using this product

Stop use and ask a doctor if

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