Fast Arthritis Aid (Capsicum Oleoresin) Gel [Concept Laboratories, Inc.] -

FAST ARTHRITIS AID (CAPSICUM OLEORESIN) GEL [CONCEPT LABORATORIES, INC.]
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NDC	64058-213-18
Set ID	98ab7e7c-80aa-46b9-81bc-158f08cd9011
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
- arthritis
- strains
- sprains
Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
When using this product do not get into eyes
- avoid contact with other mucous membranes
Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or 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
- Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
- Children under 12 years of age consult a physician
- Apply liberally to affected area not more than 3 to 4 times daily
- Gently massage into the skin until fully absorbed
- Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
Inactive ingredients

Water (Aqua), Glycerin, PEG-75 Lanolin, Polysorbate-20, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Emu Oil, Aloe Barbadensis Leaf Juice, Glucosamine HCl, Dimethyl Sulfone, Seed of Celosia Argentea Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.
SPL UNCLASSIFIED SECTION

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 www.conceptlabs.org
PRINCIPAL DISPLAY PANEL - 244g Bottle Label

NDC 64058-213-18

Immediate
Warming Relief
for Arthritis Joint &
Muscle Pain

FAST™
ARTHRITIS
AID

PAIN
RELIEVING
GEL

NET WT 8.6 OZ. (244g)

INGREDIENTS AND APPEARANCE

FAST ARTHRITIS AID
capsicum oleoresin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64058-213
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Capsicum Oleoresin (UNII: UW86K581WY) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.061 g in 244 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALFALFA LEAF (UNII: HY3L927V6M)
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GINKGO (UNII: 19FUJ2C58T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EMU OIL (UNII: 344821WD61)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ASIAN GINSENG (UNII: CUQ3A77YXI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64058-213-18	244 g in 1 BOTTLE; 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	04/17/2015

Labeler - Concept Laboratories, Inc. (962282612)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-213)

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