ULTRA THERAPY PAIN RELIEF- menthol, methyl salicylate, capsaicin lotion

ULTRA THERAPY PAIN RELIEF by

Drug Labeling and Warnings

ULTRA THERAPY PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Cal Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

METHYL SALICYLATE (28%)

MENTHOL (10%)

CAPSAICIN (0.025%)

PURPOSE

TOPICAL ANALGESIC

INDICATIONS & USAGE

USE

- TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANE

STOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Butterbur Extract, Cetearyl Alcohol and Polysorbate 60, Glucosamine HCl, Glyceryl Stearate and Peg 100 Stearate, Hydroxypropyl Methylcellulose, Isopropyl Palmitate, Phenoxyethanol, Ethylhexylglycerin, Pine Bark Extract, Prickly Ash Bark Extract, Propylene Glycol, Sichuan Peppercorn Extract , Stearyl Alcohol, Water Deionsed, Willowbark Extract, Wintergreen Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA THERAPY PAIN RELIEF 
menthol, methyl salicylate, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.025 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MARITIME PINE (UNII: 50JZ5Z98QY)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ZANTHOXYLUM BUNGEANUM WHOLE (UNII: WH9894JM8K)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
WILLOW BARK (UNII: S883J9JDYX)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-1001-2	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/29/2012

Labeler - Cal Pharma (078721283)