Capsaicin Cream 0.1% by Pharmaceutica North America, Inc. / Pure Source, LLC

Capsaicin Cream 0.1% by

Drug Labeling and Warnings

Capsaicin Cream 0.1% by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAPSAICIN CREAM 0.1%- capsaicin cream 
Pharmaceutica North America, Inc.

----------

Active Ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:
Arthritis
Simple Backache
Strains
Sprains
Bruises

Warnings

For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:

Due not use

• Do not apply to wounds, damaged, broken or irritated sin
• if you are allergic to capssicum or chili peppers

When using this product

• use only as directed
• Do not apply to wounds, damaged, broken or irritated sin
• Do not use if you are allergic to capssicum or chili peppers
• Avoid contact with the eyes or mucous membranes
• A slight burning sensation may occur upon application, but generally disappears after several days of use
• If severe burning occurs, discontinue use
• Do not expose the treated area to heat or direct sunlight
• Do not bandage
• Do not use with heating pad

Stop Use and Ask Doctor if:
Condition worsens
Symptoms persist for more than 7 days or clear up and occur again within a few days
Redness is present
irritation develops
Keep Out of the Reach of Children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more than directed (see overdose warning)
adults and children over 18 years and over:

• apply to affected area 
• massage into the painful area until throughly absorbed 
• repeat as necessary but not more than 3 to 4 times daily
• WASH HANDS WITH SOAP AND WATER AFTER APPLYING

children under 18 years and younger:ask a doctor

Other information

store at room temperature 15° - 30°C (59 - 86°F)

Inactive Ingredients

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Questions or comments? (888)788-6472

Product label

CAPSAICIN CREAM 0.1% 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-074
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLPARABEN (UNII: 14255EXE39)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
LAURETH-15 (UNII: 002FR4N8OV)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-074-04	1 in 1 BOX	02/01/2025
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2025	12/31/2025

Labeler - Pharmaceutica North America, Inc. (962739699)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(45861-074)

Revised: 12/2025

Document Id: 471bf3af-a6e3-8b91-e063-6394a90a3b64

34390-5

Set id: e248ddde-9f78-4964-ba49-a50c8db3233f

Version: 2

Effective Time: 20251229