CAPSAICIN- capsaicin cream 
PHARMACURE LLC

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Active Ingredient                                     Purpose

Capsaicin 0.035%                                      External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

Warnings

For external use only

Read all warnings and directions before use.

Test first on small area of skin.

Do not use

• On wounds or damaged skin.

• If you are allergic to capsicum or chili peppers.

When using this product

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes

• Do not tightly wrap or bandage the treated area

• Do not apply heat to the treated area immediately before or after use.

Stop use and ask a doctor if

• Conditions worsens or does not improve after regular use.
• Severe burning persists o blistering occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

 Adults and children 18 years of age and older:

Other Information

Inactive ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid

Product label

image description

CAPSAICIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79643-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.035 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HEMP (UNII: TD1MUT01Q7)  
PEG-100 MONOSTEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
RESVERATROL (UNII: Q369O8926L)  
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79643-011-011 in 1 BOX02/05/2025
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/05/2025
Labeler - PHARMACURE LLC (055983858)

Revised: 2/2025
Document Id: 2d52cb80-e148-a0bf-e063-6294a90a7f8f
Set id: b2b2de93-d957-43d7-a2a8-b46bcaea1f0d
Version: 1
Effective Time: 20250204
 
PHARMACURE LLC