Active Ingredient Purpose
Trolamine Salicylate - 10% Topical Analgesic
Real Time Pain Relief Therapeutic Hand Cream
FDA Label NDC 58133-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Real Time Pain Relief Therapeutic Hand Cream (NDC 58133-400). 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 active ingredient purpose, purpose, uses, otc - when using, directions, inactive ingredients:, package label and principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Uses: temporarily relieves minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps
Otc - When Using
When using this product • use only as directed • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin
Directions
adults and children over 2 years:
- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary, but no more than 4 times daily
children 2 years or younger: ask a doctor
Inactive Ingredients:
Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Emu Oil, Fragrance, Laureth-7, Methylsulfonylmethane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Purified Water, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Triethanolamine.
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