Capsaicin by PHARMACURE LLC CAPSAICIN cream

Capsaicin by

Drug Labeling and Warnings

Capsaicin by is a Otc medication manufactured, distributed, or labeled by PHARMACURE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin 0.025%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, sprains

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.

KEEP OUT OF REACH OF CHILDREN

Directions

 Adults and children 18 years of age and older:

• Apply a thin film of cream to affected area and gently rub in until fully absorbed.
• Unless treating hands, wash hands thoroughly with soap and water immediately after application.
• For best results, apply 3 to 4 times daily.
• Children under 18 years: ask a doctor

Other Information

• Store at room temperature 15°-30°C (59°-86°F).
• Protect product from excessive moisture.

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

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79643-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79643-006-01	100 g in 1 TUBE; Type 0: Not a Combination Product	01/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/24/2024

Labeler - PHARMACURE LLC (055983858)