SPL v1
SPL
SPL Set ID 401dd218-1c26-f9dc-e063-6294a90a7713
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Carbomer Allantoin Peg-40 Hydrogenated Castor Oil Panthenol Water Bisabolol Phenoxyethanol Glycerin Ethylhexylglycerin Menthyl Lactate Aminomethyl Propanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-13

Description

Capsaicin 0.1% w/w – External Analgesic


Medication Information

Warnings and Precautions

For external use only

Test first on a small area of skin.

Indications and Usage

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

Dosage and Administration

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

Description

Capsaicin 0.1% w/w – External Analgesic

Section 50565-1



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

Section 50567-7



■ 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

Section 50570-1



■ 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

Section 51727-6



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

Section 51945-4

Section 53414-9



ask a health professional before use.

Section 55105-1



Topical analgesic

Section 55106-9

Capsaicin 0.1% w/w – External Analgesic

Section 59845-8

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.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Test first on a small area of skin.

Section 50565-1 (50565-1)



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

Section 50567-7 (50567-7)



■ 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

Section 50570-1 (50570-1)



■ 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

Section 51727-6 (51727-6)



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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)



ask a health professional before use.

Section 55105-1 (55105-1)



Topical analgesic

Section 55106-9 (55106-9)

Capsaicin 0.1% w/w – External Analgesic

Section 59845-8 (59845-8)

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)