Otc - Active Ingredient
Active ingredients
Arnica Montana (Arnica) 1X
Hamamelis Virginiana (Witch Hazel) 1X
Magnesia Sulphurica (Magnesium Sulfate) 1X
Roovemag Magnesium Soothing Warming Cream
FDA Label NDC 76348-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Roovemag Magnesium Soothing Warming Cream (NDC 76348-403). 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 - active ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain, inflammation
Pain, Fatigue
Pain
Uses
Natural temporary relief for aches, pains and inflammation from minor injuries, overexertion and fatigue.
Natural temporary relief for aches, pains and inflammation from minor injuries, overexertion and fatigue.
Directions
Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected area 2-3 times daily or as needed.
Children less than 2 years of age: Consult a doctor.
Warnings
For external use only. Do not use on broken skin or open wounds.
Stop and ask a doctor if
Pain Persists for more than 5 days
- If pain, redness, or swelling worsens
- if new symptoms occur
If pregnant or Breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or Breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Directions
Adults and children over the age of 2 years old: Apply generously with gentle rubbing to the affected area 2 - 3 times daily or as needed.
Children less than 2 years of age: Consult a doctor.
Inactive Ingredients
Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Capsicum Frutescens (Pepper) Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Deionized Water, Emulsifying Wax, Fragrance, Glycerin, Laureth-7, Lobelia Inflata Extract, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Menthol, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Sodium Hyaluronate (Hyaluronic) Acid, Tripeptide Marine Collagen, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vegetable Oil, Xanthan Gum.
Questions Or Comments
Questions or Comments
Contact: [email protected]
Tijara, LLC
447 Broadway,
2nd Floor Suite #1188
New York, New York 10013,
United States
Roovemag Magnesium Soothing Cream 60 Ml Label
MULTI-LAYER LABEL FOR ROOVEMAG CREAM 60 ML
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