CAPSAICIN 0.035% CREAM- capsaicin cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Capsaicin 0.035%

PURPOSE

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.

Keep out of the reach of children.

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

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

• Condition worsens or does not improve after regular use
• Severe burning persists or blistering occurs

Directions

Adults and children 18 years 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 18years：ask a doctor

Other Information

excursions permitted to 15-30C(59-86F).
See USP Controlled Room Temperature.

Inactive Ingredients

Poly(acrylic acid) solution, Polysorbate 80, Glycerin, polyethylene glycol-400, Sodium polyacrylate, SORBITOL, Carboxymethyl Cellulose Sodium, aluminium magnesium silicate, PHENOXYETHANOL, EDTA Disodium salt, Lemon oil, Water, Peppermint oil

Principal Display Panel

NDC: 82461-417-10

Medcore LLC

Capsaicin 0.035% cream

100ml

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

INGREDIENTS AND APPEARANCE

CAPSAICIN 0.035% CREAM 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-417-10	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/04/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/04/2026

Labeler - Medcore LLC (069802634)