Rocksauce Warming Massage Roll-on Cream, Augmented
FDA Label NDC 81683-005

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 Warming Massage Roll-on (NDC 81683-005). 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, 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

Drug Facts

Active Ingredient

Menthol 10%

Methyl Salicylate 20%

Purpose

Topical Analgesic

Uses:

Provides soothing heat to sore muscles and joints.

Warnings:

For external use only.

When Using This Product,

do not take by mouth or pace in  nostrils, apply to wounds or damaged skin. Use as directed. 

Ask A Health Professional Before Use

if you have senstive 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 youger.

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 Ndc: ​81683-005-01

2-ETHYLHEXYL PALAMITATE, ALOE BARBADENSIS LEAF JUICE, CAPSAICIN, CARBOMER, CETEARYL ALCOHOL, DIMETHYL SILICONE OIL, METHYLPARABEN, PHENOXYETHANOL, PORTULACA OLERACEA EXTRACT, PROPYL GLYCOL, PROPYLPARABEN, SPAN 60, TRIETHANOLAMINE, TWEEN 60, WATER

81683-005-02

Label (Label)

Label (Label)

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