DRUG FACTS

Active Ingredient

Menthol 1.25%

Topical analgesic

INDICATIONS

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache.

WARNINGS

• For external use only. • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

• If swallowed, consult physician.

• Do not apply to wounds or damaged skin. • Do not bandage tightly.

If pregnant or breastfeeding,

• consult physician prior to use.

DIRECTIONS

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a physician.

ADDITIONAL INFORMATION

Store at room temperature.

OTHER INGREDIENTS

Achillea Millefolium (Yarrow) Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Annatto, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Bixa Orellana (Annatto) Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Myristoleate, Curcuma Longa (Turmeric) Root Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Harpagophytum Procumbens (Devil's Claw) Root Extract, Helianthus Annuus (Sunflower), Hyaluronic Acid, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Scutellaria Baicalensis (Skullcap) Root Extract, Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Yucca Schidigera Extract

Package Labeling:

Label2

FEEL GOOD LABS SPORT RECOVERY
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70554-291
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
YELLOW WAX (UNII: 2ZA36H0S2V)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
TURMERIC (UNII: 856YO1Z64F)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYALURONIC ACID (UNII: S270N0TRQY)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANNATTO (UNII: 6PQP1V1B6O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70554-291-00	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/03/2020

Labeler - THE FEEL GOOD LAB, LLC (087120037)

FEEL GOOD LABS SPORT RECOVERY LOTION