Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID baef8d6e-d320-44bf-a961-435791080807
Route
TOPICAL
Published
Effective Date 2012-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Benzyl Alcohol Cetyl Alcohol Citric Acid Monohydrate Glyceryl Monostearate Isopropyl Myristate Peg-100 Stearate Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-04-01
Description

Active ingredient                                                                      Purpose Capsaicin 0.1%........................................................................Topical analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

Adults and children over 18 years:

  • apply generously to affected area not more than 3 to 4 times daily
  • massage into painful area until thoroughly absorbed
  • wash hands with soap and water after use
  • close cap tightly after use
Children 18 years or younger: Ask a doctor

Dosage and Administration

Distributed By

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Visit us at

www.goodneighborpharmacy.com



Made in Korea

Description

Active ingredient                                                                      Purpose Capsaicin 0.1%........................................................................Topical analgesic

Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a 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

Section 50567-7

When using this product

  • use only as directed
  • do not bandage
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a slight burning
  • sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use
  • do not expose the treated area to heat or direct sunlight
  • do not use if allergic to capsicum or chili peppers

Section 51727-6

Inactive ingredients

Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

Section 51945-4

Enter section text here

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

For the temporary relief of minor pain associated with:

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises

Section 55106-9

Active ingredient                                                                      Purpose

Capsaicin 0.1%........................................................................Topical analgesic

Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children over 18 years:

  • apply generously to affected area not more than 3 to 4 times daily
  • massage into painful area until thoroughly absorbed
  • wash hands with soap and water after use
  • close cap tightly after use
Children 18 years or younger: Ask a doctor

Dosage and Administration (34068-7)

Distributed By

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Visit us at

www.goodneighborpharmacy.com



Made in Korea

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a 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

Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not bandage
  • do not use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a slight burning
  • sensation may occur upon application but generally disappears in several days
  • if severe burning occurs, discontinue use
  • do not expose the treated area to heat or direct sunlight
  • do not use if allergic to capsicum or chili peppers

Section 51727-6 (51727-6)

Inactive ingredients

Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

Section 51945-4 (51945-4)

Enter section text here

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

For the temporary relief of minor pain associated with:

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises

Section 55106-9 (55106-9)

Active ingredient                                                                      Purpose

Capsaicin 0.1%........................................................................Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:26.555654 · Updated: 2026-03-14T22:53:04.035717