LCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC- methyl salicylate, menthol, capsaicin cream

LCDO. ORLANDO RIVERA ARTHRITIS Topical Analgesic by

Drug Labeling and Warnings

LCDO. ORLANDO RIVERA ARTHRITIS Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LCDO. ORLANDO RIVERA ARTHRITIS CREAM Topical Analgesic

ACTIVE INGREDIENTS

Salicylate .... 15.00%
Menthol ....... 10.00%
Capsaicin  ..... 0.050%

PURPOSE

Topical Analgesic

WARNINGS

For external use only

When using this product

Consult a health care professional if you are allergic to aspirin or salicylates. Use only as directed. Do not get into eyes or mucous membranes.

Do not apply

to wounds or damaged, broken or irritated skin. do not tightly wrap or bandage. do not use with a heating pad. do not expose the treated area to external heat or direct sunlight. a burning sensation may occur upon application but generally disappears in a few days with regular use.

Stop use and ask a doctor if

condition worsens, excessive burning or irritation persists, pain persists for more than 7 days, symptoms clear up and occur again within a few days.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid.

OTHER INFORMATION

store at 15 - 30 o C (59 - 86 o F)

QUESTIONS OR COMMENTS:

www.prophrmacarepr.com

DIRECTIONS

adults and children 16 years of age and over

• apply to the affective area and gently rub it in until fully absorbed
• repeat as necessary but not more than 3 to 4 times daily
• for best results use continuously for 2 to 4 weeks
• avoid washing treated areas for at least 30 minutes after application
• unless treating hands, wash hands thoroughly with soap and water immediately after use

children under 16 consult a doctor

USES

for temporary relief of minor aches and pains of muscles and joints associated with

• arthritis
• sprains
• strains
• bruises
• simple backache

These statements have not been evaluated by the Food and Drug Administration.
The product is not intended to diagnose, treat, cure or prevent any disease.

LCDO. ORLANDO RIVERA ARTHRITIS CREAM Topical Analgesic 2oz/58g (

65121-495-02)

INGREDIENTS AND APPEARANCE

LCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC 
methyl salicylate, menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-495
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-495-02	1 in 1 CARTON	04/21/2014
1		58 g in 1 JAR; 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	04/21/2014

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-495)