Bronson Soothe Pain Relief Cream
FDA Label NDC 83158-387

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bronson Nutritionals, Llc for the product Bronson Soothe Pain Relief (NDC 83158-387). 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 drug facts, active ingredient, purpose, uses:, warnings, keep out of reach of children., directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Capsaicin 0.025%

Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.

Warnings

  • For external use only. 
  • Avoid contact with eyes.
  • Do not apply to open wounds or damaged skin.
  • If symtoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

  • If swallowed, contact physician.
  • Do not bandage tightly .
  • If pregnant or breast feeding, contact physician prior to use.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Inactive Ingredients:

Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica montana Flower Extract, Ascorbyl Palmitate (Vitamin C), C13-14 Isoparaffin, Cetyl Alcohol, Chamomilla recutita (Chamomile) Extract, Diazolidinyl Urea, Emu Oil, Hamamelis virginiana (Witch Hazel) Distillate, Isopropyl Alcohol, Isopropyl Myristate, Lamium album (White Nettle) Extract, Laureth-7, Menthol, Methyl Paraben, Methylsulfonylmethane (MSM), Parfum (Fragrance), PEG-8, Polyacrylamide, Propyl Paraben, Propylene Glycol, Sorbitol, Tocopheryl Acetate (Vitamin E).

Other Information:

  • Store at room temperature.
  • Protect from light.

Package Labeling:59Ml

Label59ml (Label59ml)

Label59ml (Label59ml)

Package Labeling:118Ml

Label118ml (Label118ml)

Label118ml (Label118ml)

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