Label: ROOVEMAG MAGNESIUM SOOTHING WARMING CREAM- arnica montana, hamamelis virginiana, magnesia sulphurica cream
- NDC Code(s): 76348-403-01
- Packager: RENU LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 8, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
-
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
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
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Uses
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.
- ROOVEMAG Magnesium Soothing Cream 60 ml LABEL
-
INGREDIENTS AND APPEARANCE
ROOVEMAG MAGNESIUM SOOTHING WARMING CREAM
arnica montana, hamamelis virginiana, magnesia sulphurica creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 0.6 g in 60 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 0.6 g in 60 g MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 0.12 g in 60 g Inactive Ingredients Ingredient Name Strength HYALURONIC ACID (UNII: S270N0TRQY) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) GRAPEFRUIT (UNII: O82C39RR8C) WHITE WAX (UNII: 7G1J5DA97F) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) LAURETH-7 (UNII: Z95S6G8201) CAPSICUM (UNII: 00UK7646FG) SHEA BUTTER (UNII: K49155WL9Y) PEPPERMINT OIL (UNII: AV092KU4JH) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG) MENTHOL (UNII: L7T10EIP3A) XANTHAN GUM (UNII: TTV12P4NEE) VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-403-01 60 g in 1 JAR; Type 0: Not a Combination Product 04/19/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2023 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-403)