ULTRACIN T: Package Insert and Label Information

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.

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
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ULTRACIN T
trolamine salicylate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55628-9047
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
(C10-C30)ALKYL METHACRYLATE ESTER
ALOE VERA LEAF
BENZOIC ACID
BOSWELLIA SERRATA WHOLE
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
GAULTHERIA PROCUMBENS LEAF
GLYCERETH-2 COCOATE
GLYCERYL MONOSTEARATE
HYPROMELLOSES
ISOPROPYL PALMITATE
PEG-100 STEARATE
PETASITES HYBRIDUS LEAF
PHENOXYETHANOL
MARITIME PINE
POLYSORBATE 60
PROPYLENE GLYCOL
WILLOW BARK
STEARYL ALCOHOL
WATER
ZANTHOXYLUM AMERICANUM BARK
ZINGIBER OFFICINALE WHOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55628-9047-4 120 mL in 1 TUBE None
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)

Revised: 11/2019 Cal Pharma

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