BLUE SPRING FOOT AND LEG COMFORT CREAM WITH PAIN RELIEF- menthol, capsaicin cream 
BLUE SPRING WELLNESS, L.L.C.

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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BLUE SPRING Foot & Leg Comfort Cream with Pain Relief

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:14448-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14448-316-00227 g in 1 JAR; Type 0: Not a Combination Product10/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/25/2021
Labeler - BLUE SPRING WELLNESS, L.L.C. (182950118)

Revised: 10/2021
Document Id: cdf6b39a-5021-6dc4-e053-2a95a90ae7e3
Set id: 2f9cf514-48be-49ec-b424-0b228b4b874a
Version: 1
Effective Time: 20211009
 
BLUE SPRING WELLNESS, L.L.C.