Label: REINA CBD INFUSED TOPICAL PAIN RELIEF- methyl salicylate, menthol lotion
- NDC Code(s): 73588-068-04
- Packager: Reina Wellness LLC
- 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 January 30, 2020
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS:
- USES:
-
WARNINGS:
Only for external use.
Do not use:
on open wounds, cuts damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucosus membranes.
- DIRECTIONS: (Store in a cool dry place)
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INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cannabis Sativus (Full Spectrum Hemp) Seed Oil, Capsaicin, Chamomilla Recutita (Chamomile) Extract, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Gluconolactone, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) oil, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonylmethane (MSM), Magnesium Sulfate, Pantothenic Acid (Vitamin B5), Pyridoxine (Vitamin B6), Salix Nigra (Willow) Bark Extract, Sodium Benzoate, Sorbitan Olivate, Squalane, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
REINA CBD INFUSED TOPICAL PAIN RELIEF
methyl salicylate, menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73588-068 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 100 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPSAICIN (UNII: S07O44R1ZM) CHAMOMILE (UNII: FGL3685T2X) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) CETYL MYRISTOLEATE (UNII: 87P8K33Q5X) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LICORICE (UNII: 61ZBX54883) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PANTOTHENIC ACID (UNII: 19F5HK2737) SALIX NIGRA BARK (UNII: QU52J3A5B3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN OLIVATE (UNII: MDL271E3GR) SQUALANE (UNII: GW89575KF9) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73588-068-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/20/2020 Labeler - Reina Wellness LLC (117245556)