ULTRA THERAPY PAIN RELIEF- menthol, methyl salicylate and capsaicin lotion 
Cal Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

METHYL SALICYLATE (28%)

MENTHOL (10%)

CAPSAICIN (0.025%)

TOPICAL ANALGESIC

USE

- TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

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. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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 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

Therapy Gels_Pain_20130423

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 DEA Schedule     
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
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)

Revised: 6/2013
Document Id: 64cb6819-dc8d-408c-b19d-5791a4a96723
Set id: 3d42ba94-0a53-4cc2-bda4-a4284c28c974
Version: 10
Effective Time: 20130613
 
Cal Pharma