Drug Labeling and Warnings

Drug Details

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ULTRACIN T- trolamine salicylate 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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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. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

Ultracin T green copy

ULTRACIN T 
trolamine salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-9047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
(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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-9047-4120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/04/2015
Labeler - Cal Pharma (078721283)
Registrant - Cal Pharma (078721283)

Revised: 8/2015
 
Cal Pharma


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