Active Ingredient
Methyl Salicylate 20%
Menthol 10%
Capsaicin0.002%
Rocksauce Fiery Hot Pain Relief Cream
FDA Label NDC 81683-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Implus Footcare, Llc for the product Rocksauce Fiery Hot Pain Relief (NDC 81683-112). 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, uses:, warnings:, when using this product, do not:, otc - do not use, otc - ask doctor, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
Provides soothing heat to sore muscles and joints.
Warnings:
For external use only. Avoid contact with eyes, mucous membrane or broken skin.
When Using This Product, Do Not:
heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.
Otc - Do Not Use
Do not use otherwise than as directed.
Otc - Ask Doctor
Consult a doctor and discontinue use if irritation occurs.
Ask a health professional before use if pregnant or breastfeeding.
Ask a doctor before using if you have sensitive skin.
Keep Out Of Reach Of Children:
In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.
Directions:
Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).
Inactive Ingredients:
Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water
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