Pure Relief (Capsaicin) Cream [Concept Laboratories, Inc.] -

PURE RELIEF (CAPSAICIN) CREAM [CONCEPT LABORATORIES, INC.]
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NDC	64058-356-34
Set ID	5523f9bf-6ff6-4fd3-98ff-ada1bfa03b6b
Category	HUMAN OTC DRUG LABEL
Packager	Concept Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)
Purpose

Pain Relieving
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- sprains
Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, wrap, hot water bottle or any heating element.
When using this product avoid eye contact
- avoid contact with mucous membranes
Stop use and ask a doctor if condition worsens
- if symptoms persist for more than 7 days
- clear up and occur again within a few days
Keep out of reach of children.
- if swallowed, get medical help or contact a Poison Control center right away
- if pregnant or nursing, seek the advice of a health professional before using
Directions
- for adults only
- apply a thin layer to affected area not more than 4 times daily
- gently massage into the skin until fully absorbed
- wash hands with soap and water after each application to avoid spreading to sensitive mucous membranes
Other information
- Excess product can be removed with a soft cloth and cooking oil.
- If applying product to hands, wait 30 minutes before washing.
- Avoid water, heat, or direct sunlight while using product.
- If wearing contact lenses, insert prior to application and avoid touching them after applying product.
- If eye contact occurs, flush immediately with water.
Inactive ingredients

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.
SPL UNCLASSIFIED SECTION

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 (USA) www.conceptlabs.org
#CL9783-R2
PRINCIPAL DISPLAY PANEL - 113 g Jar Label

EFFECTIVE RELIEF

PURE RELIEF™
PAIN RELIEVING CREAM

WITH MOISTURIZING ALOE,
EMU OIL & GLUCOSAMINE

NET WT. 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

PURE RELIEF
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64058-356
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	2.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
LAURYL LAURATE (UNII: GPW77G0937)
STARCH, CORN (UNII: O8232NY3SJ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALFALFA (UNII: DJO934BRBD)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
ROSEMARY (UNII: IJ67X351P9)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GINKGO (UNII: 19FUJ2C58T)
FLAX SEED (UNII: 4110YT348C)
CELOSIA ARGENTEA SEED (UNII: O1H314U8M2)
ACAI (UNII: 46AM2VJ0AW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EMU OIL (UNII: 344821WD61)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64058-356-34	113 g in 1 JAR; Type 0: Not a Combination Product	12/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	12/06/2016

Labeler - Concept Laboratories, Inc. (962282612)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-356)

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