Otc - Purpose
PURPOSE: Topical analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Home Aide Diagnostics, Inc. for the product Rotex (NDC 69379-038). 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 - purpose, otc - active ingredient, indications & usage, warnings, dosage & administration, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
PURPOSE: Topical analgesic
ACTIVE INGREDIENTS
Methyl Salicylate 35% ----------------------------- Counterirritant
Capsaicin 0.038% ----------------------------------- Counterirritant
Menthol 4% ---------------------------------------- Topical analgesic
INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:
WARNINGS
FOR EXTERNAL USE ONLY.
DIRECTIONS
Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.
STOP USE AND ASK A DOCTOR IF:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
If pregnant of breast-feeding, ask a healthcare professional before use
INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water
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