Drug Labeling and Warnings

Drug Details

k">

ULTRACIN- methyl salicylate, menthol, 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

Aloe Barbadensis (Aloe) Leaf Juice,Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Boswelia Serrata Extract, Butterbur Extract,Cetearyl Alcohol and Polysorbate 60, Glyceryl Stearate and PEG 100 Stearate, Hydroxypropyl Methylcellulose,Isopropyl Myristate, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol and Ethylhexylglycerin,Pine Bark Extract, Polaxamer, Prickly Ash Extract, Propylene Glycol, Sichuan Peppercorn Extract, Soya Lecithin, Stearyl Alcohol, Water, Willowbark Extract, Wintergreen Extract, Zingiber Ocinale Root Extract

Ultracin _REV01

ULTRACIN 
methyl salicylate, menthol, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-9179
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) CAPSAICIN25 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
TUSSILAGO FARFARA LEAF (UNII: G2GH7V846Z)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MARITIME PINE (UNII: 50JZ5Z98QY)  
POLOXAMER 124 (UNII: 1S66E28KXA)  
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ZANTHOXYLUM BUNGEANUM WHOLE (UNII: WH9894JM8K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
WILLOW BARK (UNII: S883J9JDYX)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-9179-4120 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 55628-9179-130 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC: 55628-9179-260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/29/2012
Labeler - Cal Pharma (078721283)
Registrant - Cal Pharma (078721283)

Revised: 4/2015
 
Cal Pharma


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.