Label: OP 6 MENTHOL WARMING ROLL ON- menthol liquid
- NDC Code(s): 76348-660-01, 76348-660-03
- Packager: RENU LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 11, 2021
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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 Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.
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INGREDIENTS AND APPEARANCE
OP 6 MENTHOL WARMING ROLL ON
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-660 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.2 g in 84 g Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) WITCH HAZEL (UNII: 101I4J0U34) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) PINENE (UNII: 996299PUKB) ARNICA MONTANA (UNII: O80TY208ZW) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ISOPROPYL ALCOHOL (UNII: ND2M416302) CANNABIDIOL (UNII: 19GBJ60SN5) LIMONENE, (+)- (UNII: GFD7C86Q1W) TABASCO PEPPER (UNII: J1M3NA843L) MYRCENE (UNII: 3M39CZS25B) CARYOPHYLLENE (UNII: BHW853AU9H) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-660-01 1 in 1 BOX 08/02/2021 1 NDC:76348-660-03 84 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/02/2021 Labeler - RENU LABORATORIES, INC. (945739449) Registrant - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-660)