Drug Labeling and Warnings

Drug Details

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ULTRA THERAPY PAIN RELIEF- menthol, methyl salicylate, 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.

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.025 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-1001-2120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/29/2012
Labeler - Cal Pharma (078721283)

Revised: 6/2013
 
Cal Pharma


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