ALCIS DAILY RELIEF PAIN RELIEF- trolamine salicylate cream

Alcis Daily Relief Pain Relief by

Drug Labeling and Warnings

Alcis Daily Relief Pain Relief by is a Otc medication manufactured, distributed, or labeled by Alcis Topical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients Trolamine Salicylate 10%: Purpose ; Topical Analgesic

PURPOSE

INDICATIONS & USAGE

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 DOCTOR

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

• Avoid direct contact with eyes or mucous membranes
• Do not apply to wounds or damaged skin

STOP USE

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.

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

INACTIVE INGREDIENT

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

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

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

ALCIS DAILY RELIEF PAIN RELIEF 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58132-3331
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58132-3331-2	1 in 1 CARTON
1		59.1 mL in 1 TUBE
2	NDC: 58132-3331-3	1 in 1 CARTON
2		88.7 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/09/2009

Labeler - Alcis Topical, Inc. (078787365)