MOISTURIZING GLUCOSAMINE BRAND- capsaicin gel

Moisturizing Glucosamine Brand by

Drug Labeling and Warnings

Moisturizing Glucosamine Brand by is a Otc medication manufactured, distributed, or labeled by Concept Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• bruises

Warnings

For external use only.

• do not apply to wounds or damaged skin
• do not bandage tightly
• do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

• avoid contact with other 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 18 years of age and older
• Apply a thin layer 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

Other information

• It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction.
• A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product 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), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCl, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.

Questions or comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

Moisturizing
Glucosamine
BRAND

NDC: 64058-113-13

Pain Relief
Roll-On Gel

ODORLESS
GREASELESS
STAINLESS

Natural Ingredients
with .025% Capsaicin
& Soothing Aloe Vera

For Temporary Relief of Minor Pain due to Arthritis, Sprains and Strains

3 fl oz.
(88mL)

INGREDIENTS AND APPEARANCE

MOISTURIZING GLUCOSAMINE BRAND 
capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.02125 g  in 85 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-113-13	85 g in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2010
2	NDC: 64058-113-49	255 g in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/16/2010

Labeler - Concept Laboratories (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories		962282612	MANUFACTURE(64058-113)