CAPSAICIN 0.05% CREAM- capsaicin 0.05% cream

Capsaicin 0.05% Cream by

Drug Labeling and Warnings

Capsaicin 0.05% Cream by is a Otc medication manufactured, distributed, or labeled by Puretek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Warnings

For external use only
This is not a face cream. Do not apply to the face.
Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
Do not apply to wounds or damaged , broken, sunburned, chapped or irritated skin.
Do not bandage tightly.
Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous
exercise. Warm water, perspiration or open pores can intensify the impact of this product
and burning sentation.
Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase
risk of serious burns.

When using this product

Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. if swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Directions

Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.
Before using on children under 18 years of age consult a physician.
Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to
small area to test for sensitivity or skin reaction.
Gently massage into the skin until fully absorbed.
Wash hands with soap and water thoroughly after each application to avoid spreading to the
eyes or other sensitive mucous membranes.

Other Information

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.

Label

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

INGREDIENTS AND APPEARANCE

CAPSAICIN 0.05% CREAM 
capsaicin 0.05% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSAICIN	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GINGER (UNII: C5529G5JPQ)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
BISABOLOL (UNII: 24WE03BX2T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
AQUA (UNII: 059QF0KO0R)
GINKGO BILOBA LEAF (UNII: 19FUJ2C58T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SILICA (UNII: ETJ7Z6XBU4)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PYRIDOXINE HCL (UNII: 68Y4CF58BV)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%) (UNII: 5F4963KLHS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-223-08	120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/30/2025

Labeler - Puretek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
Puretek Corporation		785961046	manufacture(59088-223)