Bluespring Doctors Pain Formula Pain Relief Cream
FDA Label NDC 83591-629

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aca Management Llc for the product Bluespring Doctors Pain Formula Pain Relief (NDC 83591-629). 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 product facts, active ingredient, purpose, uses, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Product Facts

Active Ingredient

Menthol, USP 1.4%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains associated with • arthritis • simple backache • sprains • strains • bruises

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 bandage 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 few days.

If Pregnant Or Breast-Feeding

ask a health professional before use. Consult a doctorbefore use on children under 12 years of age if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2 years of age.

Keep Out Of Reach Of Children.

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

Other Information

Store at room temperature.

Directions

  • Apply to affected area not more than 3 or 4 times a day. Consult a doctorbefore using for children under 12 for arthritic conditions and for all children under 2 years of age for all other uses.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centaurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Glycerin (plant based), Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract.

Questions Or Comments?

Call 1-855-290-7111or visit www.painrelief.md

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