REINA CBD INFUSED TOPICAL PAIN RELIEF- methyl salicylate, menthol lotion
Reina Wellness LLC

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.

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REINA CBD INFUSED TOPICAL PAIN RELIEF LOTION

DRUG FACTS

ACTIVE INGREDIENTS:

Methyl Salicylate 10%

Menthol 4%

PURPOSE

Topical Analgesic

USES:

Temporarily relieves inflammation, mild aches and pains of muscle joints.

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.

Consult your physician:

if pain is persistent or worsens or if using any other topical pain products.
Call poison control if swallowed. If contact with eyes occurs, rinse eyes thoroughly with cold water.

Keep out of reach of children.

Consult physician for children under 12.

DIRECTIONS: (Store in a cool dry place)

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately aftwards and avoid contact with eyes.

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:

Label

REINA CBD INFUSED TOPICAL PAIN RELIEF
methyl salicylate, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73588-068
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73588-068-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2020	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/20/2020	12/31/2021

Labeler - Reina Wellness LLC (117245556)

Revised: 1/2022

Document Id: d58d1ec6-46ed-413e-e053-2a95a90a3a2c

Set id: a39ff67c-473c-4578-84d2-16934270b236

Version: 2

Effective Time: 20220114

Reina Wellness LLC