Otc - Active Ingredient
| Active ingredients Trolamine Salicylate 10% | Purpose Topical Analgesic |
Alcis Daily Relief Pain Relief
FDA Label NDC 58132-3331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alcis Topical, Inc. for the product Alcis Daily Relief Pain Relief (NDC 58132-3331). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - ask doctor, when using this product, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - 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.
Otc - 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.
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
Otc - Questions
Questions or comments? 1-800-977-8123
www.alcis.com
Other
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 (B5b1f3a2 7fba 4c2e Aee9 A0bf28ae1364 01)
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