ALCIS DAILY RELIEF PAIN RELIEF- trolamine salicylate cream 
Alcis Topical, Inc.

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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Drug Facts

Active ingredients
Trolamine Salicylate 10%
Purpose
Topical Analgesic

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises.

Warnings

For External Use Only

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate. Before use on children under 2 years of age, consult a physician.

When using this product

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center Immediately.

Directions-Massage a generous amount onto muscles, joints or affected area. Repeat as necessary, up to 3-4 times daily.

Inactive Ingredients: Camellia oleifera Leaf Extract, Caprylic/Capric/Myristic/Stearic Triglyceride, Chamomilla recutita (Matricaria) Flower Extract, Chamomilla recutita (Matricaria) Oil, Cyclomethicone, Cetyl Alcohol, Dimethicone, Dimethyl Sulfone, Disodium EDTA, Fragrance, Glucosamine Sulfate, Glyceryl Monostearate, Imidurea, Lavandula angustifol (lavender) Extract, Methylparaben, PEG-12 Glyceryl Distearate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Rosmarinus officinalis (Rosemary) Oil, Sodium Metabisulfite, Stearyl Alcohol, Tocopheryl Acetate, Vitis vinifera (Grape) Seed Extract, Xanthan Gum

Questions or comments? 1-800-977-8123
www.alcis.com

Manufactured in USA by Biozone Laboratories
Distributed by ALCiS Topical, Inc., Santa Clara, CA 95051 Rev.

PRINCIPAL DISPLAY PANEL - 88.7 mL container

NDC 58132-3331-02

works in as little as 5 minutes

ALCiS®
THE SCIENCE OF RELIEF®

DAILY RELIEF

PAIN RELIEF CREAM

engineered therapy
for muscles and jointsTM

with nourishing botanicals
and antioxidants to rejuvenate skin

2 fl oz / 59.15 ml

Manufactured in USA by Biozone Laboratories
Distributed by ALCiS Topical, Inc., Santa Clara, CA 95051 Rev.

Trolamine Salicylate 10% Carton Image 1
ALCIS DAILY RELIEF PAIN RELIEF 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58132-3331
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
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CHAMOMILE (UNII: FGL3685T2X)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
IMIDUREA (UNII: M629807ATL)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58132-3331-21 in 1 CARTON
159.1 mL in 1 TUBE
2NDC:58132-3331-31 in 1 CARTON
288.7 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/09/2009
Labeler - Alcis Topical, Inc. (078787365)

Revised: 6/2013
Document Id: c2b362c3-36dc-40ef-91be-242d45a09b47
Set id: b5b1f3a2-7fba-4c2e-aee9-a0bf28ae1364
Version: 2
Effective Time: 20130628
 
Alcis Topical, Inc.