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| Product NDC Code | 83158-387 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bronson soothe pain relief |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 198555 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | BRONSON NUTRITIONALS, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Capsaicin 0.025% PURPOSE External Analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS: Apply directly to affected area. Do not use more than four times per day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES: For temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.
Purpose
Information about the drug product’s indications for use.PURPOSE External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.BRONSON SOOTHE Pain Relief CAPSAICIN ALOE VERA LEAF WATER ARNICA MONTANA FLOWER ASCORBYL PALMITATE C13-14 ISOPARAFFIN CETYL ALCOHOL CHAMOMILE DIAZOLIDINYL UREA EMU OIL WITCH HAZEL ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE LAMIUM ALBUM WHOLE LAURETH-7 MENTHOL METHYLPARABEN DIMETHYL SULFONE POLYETHYLENE GLYCOL 400 PROPYLPARABEN PROPYLENE GLYCOL SORBITOL .ALPHA.-TOCOPHEROL ACETATE CAPSAICIN CAPSAICIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling:59ml Label59ml
Package Labeling:118ml Label118ml
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
OTHER INFORMATION: Store at room temperature. Protect from light.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, contact physician. Do not bandage tightly . If pregnant or breast feeding, contact physician prior to use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API