ULTRACIN- methyl salicylate, menthol, capsaicin lotion

ULTRACIN by

Drug Labeling and Warnings

ULTRACIN 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRACIN 
methyl salicylate, menthol, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9179
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	25 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9179-4	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/29/2012
2	NDC: 55628-9179-1	30 mL in 1 TUBE; Type 0: Not a Combination Product	11/29/2012
3	NDC: 55628-9179-2	60 mL in 1 BOTTLE; 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)

Registrant - Cal Pharma (078721283)