ULTRACIN T- trolamine salicylate lotion

ULTRACIN T by

Drug Labeling and Warnings

ULTRACIN T by is a Otc medication manufactured, distributed, or labeled by Cal Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TROLAMINE SALICYLATE 10%

PURPOSE

TOPICAL ANALGESIC

USE:

TEMPORARILY RELIEVES MILD ACHES, PAINS, AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH WITH NERVE DAMAGE AND SPORT INJURIES

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.

PREGNANCY OR BREAST FEEDING

IF PREGNANT OR BREAST FEEDING, ASK A HHEALTHCARE PROFESSIONAL BEFORE USE.

DIRECTIONS

ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED.

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe) Leaf Juice, Benzoic Acid, Boswellia Serrata Gum, Cetearyl Alcohol, Ethylhexylglycerin, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycereth-2 Cocoate, Glyceryl Stearate, Hydroxypropyl Methyl Cellulose, Isopropyl Palmitate, Peg-100 Stearate, Petasites Vulgaris( Butterbur) Leaf Extract, Phenoxyethanol, Pinus Pinaster Bark Bud Extract, Polysorbate 60, Propylene Glycol, Salix Alba (Willow) Bark Extract, Stearyl Alcohol, Water, Zanthoxylum Americanum( Prickly Ash) Bark Extract, Zingiber Officinale (Ginger) Root Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRACIN T 
trolamine salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 STEARATE (UNII: YD01N1999R)
PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MARITIME PINE (UNII: 50JZ5Z98QY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WILLOW BARK (UNII: S883J9JDYX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9047-4	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/04/2015

Labeler - Cal Pharma (078721283)

Registrant - Cal Pharma (078721283)