Capsaicin

Cream · Topical

Over the counter 1 recall

Active ingredient

Active ingredient Capsaicin 0.025%

Purpose

Purpose External analgesic

Uses

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

Warnings

Warnings For external use only . Use only as directed or as directed by a health care professional Read all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. Whe n us ing 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 as k a physician:
• If pregnant or breast feeding
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
• If severe burning persists or blistering occurs Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use

Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

When using this product

Whe n us ing 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

Stop use and as k a physician:
• If pregnant or breast feeding
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
• If severe burning persists or blistering occurs

Keep out of reach of children

Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Directions Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years : Ask a physician

Other information

Other information Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Inactive ingredients Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt

Label text from the FDA structured product label by Alexso, Inc (revised Mar 19, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Capsaicin in 16 products

Capsaicin NDC products (16)

NDC	Strength & form	Labeler	Type
50488-1025	Capsaicin .025 g/100g Cream	Alexso, Inc	OTC MONOGRAPH DRUG
50488-2025	Capsaicin .025 g/100g Patch	Alexso, Inc	OTC MONOGRAPH DRUG
71436-3025	Capsaicin .025 g/100g Patch	ARI BRANDS, LLC	OTC MONOGRAPH DRUG
76420-753	Capsaicin .1 g/100g Cream	Asclemed USA, Inc.	OTC MONOGRAPH DRUG
50268-195	Capsaicin .25 mg/g Cream	AvPAK	OTC MONOGRAPH DRUG
50268-196	Capsaicin .75 mg/g Cream	AvPAK	OTC MONOGRAPH DRUG
50268-197	Capsaicin .001 g/g Cream	AvPAK	OTC MONOGRAPH DRUG
50268-198	Capsaicin .1 g/100g Cream	AvPAK	OTC MONOGRAPH DRUG
68071-3430	Capsaicin .25 mg/g Cream	NuCare Pharmaceuticals,Inc.	OTC MONOGRAPH DRUG
79643-002	Capsaicin .025 g/100g Patch	PHARMACURE LLC	OTC MONOGRAPH DRUG
79643-007	Capsaicin .035 g/100g Patch	PHARMACURE LLC	OTC MONOGRAPH DRUG
79643-011	Capsaicin .035 g/100g Cream	PHARMACURE LLC	OTC MONOGRAPH DRUG
79643-012	Capsaicin .05 g/100g Patch	PHARMACURE LLC	OTC MONOGRAPH DRUG
0536-2525	Capsaicin .25 mg/g Cream	Rugby Laboratories	OTC MONOGRAPH DRUG
69420-6025	Capsaicin .025 g/100g Cream	SA3, LLC	OTC MONOGRAPH DRUG
69420-7025	Capsaicin .025 g/100g Patch	SA3, LLC	OTC MONOGRAPH DRUG

Capsaicin recalls

D-1147-2023 Sep 13, 2023 · Class II · Terminated
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Frequently asked questions

What is Capsaicin used for?

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

Who makes Capsaicin?

Capsaicin is listed by 8 labelers in the FDA NDC directory, including Alexso, Inc, ARI BRANDS, LLC, Asclemed USA, Inc., AvPAK.

Has Capsaicin been recalled?

The FDA enforcement database lists 1 recall for Capsaicin, most recently D-1147-2023 (class ii): Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste