Bronson Soothe Cream Pain Relief Cream

Bronson Soothe Cream Pain Relief Cream
SPL v2
SPL
SPL Set ID cedf8f43-b9a3-4a06-b3a1-cf82668541f8
Route
TOPICAL
Published
Effective Date 2022-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-26

Description

Capsaicin 0.025%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Capsaicin 0.025%

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.
Drug Facts

Directions:

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

Active Ingredient

Capsaicin 0.025%

Other Information:
  • Store at room temperature.
  • Protect from light.
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).

Package Labeling:59ml

Package Labeling:118ml

Keep Out of Reach of Children.
  • If swallowed, contact physician.
  • Do not bandage tightly .
  • If pregnant or breast feeding, contact physician prior to use.

Structured Label Content

Uses: (USES:)

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

Purpose (PURPOSE)

External Analgesic

Warnings (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.
Drug Facts

Directions: (DIRECTIONS:)

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

Active Ingredient (ACTIVE INGREDIENT)

Capsaicin 0.025%

Other Information: (OTHER INFORMATION:)
  • Store at room temperature.
  • Protect from light.
Inactive Ingredients: (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).

Package Labeling:59ml

Package Labeling:118ml

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, contact physician.
  • Do not bandage tightly .
  • If pregnant or breast feeding, contact physician prior to use.

Advanced Ingredient Data


Raw Label Data

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