DR. LUKE CAPSAICIN CREAM EXTRA STRENGTH- capsaicin cream

Dr. Luke Capsaicin Cream by

Drug Labeling and Warnings

Dr. Luke Capsaicin Cream by is a Otc medication manufactured, distributed, or labeled by DANOUS LAND FLOOW LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin 0.1% w/w – External Analgesic

WHEN USING

■ use only as directed ■ do not apply to wounds, broken or irritated skin ■ avoid contact with eyes or mucous membranes ■ a burning, stinging or warming sensation may occur upon application and generally lessens with continued use; if severe burning occurs, discontinue use ■ do not bandage tightly ■ do not use with a heating pad or right after bathing/shower ■ do not expose the treated area to heat or direct sunlight ■ do not use at the same time as other topical analgesics

DO NOT USE

■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ excessive irritation/redness, swelling, blistering or signs of skin injury develop

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

WARNINGS

For external use only
Test first on a small area of skin.

INACTIVE INGREDIENT

Purified Water, Glycerin, 1,3-Propanediol, Carbomer, Aminomethyl Propanol (pH adjuster), Menthyl Lactate, Panthenol, Bisabolol, Allantoin, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Ethylhexylglycerin.

INSTRUCTIONS FOR USE

Adults:

apply a thin layer to affected area and massage until absorbed; repeat up to 3–4 times daily as needed.
Wash hands with soap and water immediately after applying.

Children under 18 years:

ask a doctor.

For sensitive skin, start once daily for 2–3 days, then increase as tolerated.

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

DOSAGE & ADMINISTRATION

Apply to affected area not more than 3–4 times daily.

PURPOSE

Topical analgesic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. LUKE CAPSAICIN CREAM  EXTRA STRENGTH
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87147-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER (UNII: 0A5MM307FC)
ALLANTOIN (UNII: 344S277G0Z)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
BISABOLOL (UNII: 24WE03BX2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87147-003-01	114 g in 1 JAR; Type 0: Not a Combination Product	10/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/13/2025

Labeler - DANOUS LAND FLOOW LLC (067045402)