Ultracin (Methyl Salicylate, Menthol, Capsaicin) Lotion [Cal Pharma] -

ULTRACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [CAL PHARMA]
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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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