Label: SOLID ROOTS ROLL-ON RELIEF- menthol 3 percent liquid
- NDC Code(s): 76348-481-01
- Packager: RENU LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated June 13, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)
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INGREDIENTS AND APPEARANCE
SOLID ROOTS ROLL-ON RELIEF
menthol 3 percent liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-481 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.84 g in 28 g Inactive Ingredients Ingredient Name Strength GRAPEFRUIT (UNII: O82C39RR8C) WATER (UNII: 059QF0KO0R) METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) PEPPERMINT OIL (UNII: AV092KU4JH) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) MAGNESIUM OROTATE (UNII: GI96W46M5A) LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ARNICA MONTANA (UNII: O80TY208ZW) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) ISOPROPYL ALCOHOL (UNII: ND2M416302) CANNABIDIOL (UNII: 19GBJ60SN5) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) WITCH HAZEL (UNII: 101I4J0U34) MAGNESIUM MYRISTATE (UNII: Z1917F0578) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-481-01 28 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 06/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/13/2022 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-481)