BRONSON SOOTHE PAIN RELIEF- capsaicin cream 
BRONSON NUTRITIONALS, LLC

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BRONSON SOOTHE CREAM Pain Relief Cream

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

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:

Package Labeling:59ml

Label59ml

Package Labeling:118ml

Label118ml

BRONSON SOOTHE PAIN RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83158-387
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHAMOMILE (UNII: FGL3685T2X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EMU OIL (UNII: 344821WD61)  
WITCH HAZEL (UNII: 101I4J0U34)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)  
LAURETH-7 (UNII: Z95S6G8201)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83158-387-0259 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2022
2NDC:83158-387-04118 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/26/2022
Labeler - BRONSON NUTRITIONALS, LLC (130393494)

Revised: 11/2023
Document Id: 0976edf3-b97e-fff9-e063-6294a90a2c4e
Set id: cedf8f43-b9a3-4a06-b3a1-cf82668541f8
Version: 2
Effective Time: 20231106
 
BRONSON NUTRITIONALS, LLC