Active Ingredient:

Menthol, USP (1.5%), Capsaicin (0.025%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains of muscles and joints.

Warnings:

For external use only.

Do not use

on wounded, damaged or irritated skin.

When using this product

avoid contact with eyes or mucous membranes, do not bandaged tightly.

Stop use and ask a doctor if

you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days.

If Pregnant or Breast-Feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Centaurea Cyanus (Cornflower) Extrat, Chamomilla Recutita (Chamomile) Extract, Coriandrum Satiyum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, Hamamelis Virgiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfony Methane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tillia Cordata (Linden) Bark Extarct, Triethanolamine, Fever Few Extract, FD&C Blue#1, FD&C Yellow #5.

Questions or Comments?

1.800.452.3700 or www.bluespringwellness. com

Package Labeling:

Label

BLUE SPRING FOOT AND LEG COMFORT CREAM WITH PAIN RELIEF
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14448-316
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE WHOLE (UNII: 7NF3GE7IWR)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CHAMOMILE (UNII: FGL3685T2X)
CORIANDER (UNII: 1OV56052IK)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WITCH HAZEL (UNII: 101I4J0U34)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SALIX ALBA BARK (UNII: 205MXS71H7)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14448-316-00	227 g in 1 JAR; Type 0: Not a Combination Product	10/25/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/25/2021

Labeler - BLUE SPRING WELLNESS, L.L.C. (182950118)

BLUE SPRING Foot & Leg Comfort Cream with Pain Relief