Otc - Purpose
Uses: Temporarily relives minor muscular discomfort
Rock Sauce
FDA Label NDC 59663-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shine & Pretty (usa), Corp. for the product Rock Sauce (NDC 59663-100). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, otc - active ingredient, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
When using this product, do not: heat, microwave, add to hot water or any container where heating water may cause splatterring and result in burns, use in eyes or directly on mucus membrane, take by month or place in nostrils, apply to wounds or damaged skin.
Warnings
Warnings: For external use only. Avoid contact with eyes. Ask a doctor before use if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.
Dosage & Administration
Directions: For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily.
Inactive Ingredient
Inactive Ingredients: D. I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Propylene Glycol, Arnica Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutarontrile
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children: In case of accidental ingestions, get medical help or call Poison Control Center right away.
Otc - Active Ingredient
Active Ingredient
Methyl Salicylate 20%
Menthol 10%
Capsicum 0.05%
Information For Patients
Consult a doctor and discontinue use: If conditions persist for more than 1 week or reoccur.
Package Label.Principal Display Panel
MM1
Label (Label2)
* Please review the disclaimer below.
