Blue Spring Foot And Leg Comfort Cream With Pain Relief Cream
FDA Label NDC 14448-316

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blue Spring Wellness, L.l.c. for the product Blue Spring Foot And Leg Comfort Cream With Pain Relief (NDC 14448-316). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

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