SPL v1
SPL
SPL Set ID 2850f7e7-41dd-f5f9-e063-6394a90ae519
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Alcohol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Water Glycerin Aminomethyl Propanol Propylene Glycol

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-09
Description

Capsaicin 0.1%

Medication Information

Warnings and Precautions

For external use only

Flammable

  • keep away from excessive heat or open flame

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Indications and Usage

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • muscle strains
  • sprains
  • bruises
  • simple backache
Dosage and Administration

Capsaicin 0.1%

Topical analgesic

Description

Capsaicin 0.1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Children 18 years of age or younger: ask a doctor

Section 50567-7

When using this product

  • do not bandage tightly or cover treated area
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Directions adults and children over 18 years of age:

  • apply to affected area
  • massage into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • wash hands with soap and water after applying
Section 51727-6

alcohol denatured

aminomethyl propanol

carbomer

glycerin

propylene glycol

water

Section 51945-4

Thermacare Heat Therapy™

Penetraing CAPSAICIN soothes nerves

ARTHRITIS & NERVE PAIN THERAPY

CAPSAICIN ROLL ON

Soothes Aggravated Nerves

Deep Penetrating Warmth

Long Lasting, Fast Acting

0.1% Capsaicin

No Mess Roll On

NET WT. 2.5 oz (70.8 g)

Section 53413-1

call 1-800-323-3383

Section 55105-1

Topical analgesic

Section 55106-9

Capsaicin 0.1%

Structured Label Content

Indications and Usage (34067-9)

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • muscle strains
  • sprains
  • bruises
  • simple backache
Dosage and Administration (34068-7)

Capsaicin 0.1%

Topical analgesic

Warnings and Precautions (34071-1)

For external use only

Flammable

  • keep away from excessive heat or open flame

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Children 18 years of age or younger: ask a doctor

Section 50567-7 (50567-7)

When using this product

  • do not bandage tightly or cover treated area
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Directions adults and children over 18 years of age:

  • apply to affected area
  • massage into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • wash hands with soap and water after applying
Section 51727-6 (51727-6)

alcohol denatured

aminomethyl propanol

carbomer

glycerin

propylene glycol

water

Section 51945-4 (51945-4)

Thermacare Heat Therapy™

Penetraing CAPSAICIN soothes nerves

ARTHRITIS & NERVE PAIN THERAPY

CAPSAICIN ROLL ON

Soothes Aggravated Nerves

Deep Penetrating Warmth

Long Lasting, Fast Acting

0.1% Capsaicin

No Mess Roll On

NET WT. 2.5 oz (70.8 g)

Section 53413-1 (53413-1)

call 1-800-323-3383

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Capsaicin 0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.172554 · Updated: 2026-03-14T23:05:33.999008