Rocksauce Cooling Massage Gel
FDA Label NDC 81683-008
10 label sections · Submitted to the FDA by Implus Footcare, Llc · 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 Cooling Massage Gel (NDC 81683-008). 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 drug facts, active ingredient, purpose, uses:, warnings:, when using this product,, ask a health professional before use if you have, 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
Active Ingredient
Menthol 6%
Purpose
Topical Analgesic
Uses:
Provides cooling sensation to sore muscles and joints
Warnings:
For external use only.
When Using This Product,
do not take by mouth or place in nostrils, apply to wounds or damaged skin. Use as directed.
Ask A Health Professional Before Use If You Have
sensitive skin or are pregnant or breastfeeding. Discontinue use if irritation occurs.
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°F (20° to 25°C)
Inactive Ingredients:
Aloe Barbadensis, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Extract, Camphor Oil, Carbomer, Chamomilla Recutita (Matricaria) Flower, Ethanol, Glycerol, Isopropyl Myristate, Maltodextrin, Mate Extract, Tea Extract, Water
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