SPL v2
SPL
SPL Set ID 780f5612-0457-400e-92f4-3a5ee53dde6e
Route
TOPICAL
Published
Effective Date 2016-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Benzyl Alcohol Cetyl Alcohol Isopropyl Myristate Polyoxyl 40 Stearate Water Sorbitan Monostearate Sorbitol Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-11-30
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

DIST. BY MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.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, isopropyl myristate, polyoxyl 40 stearate, purified water, sorbitan, monostearate, sorbitol solution, white petrolatum

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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)

DIST. BY MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.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, isopropyl myristate, polyoxyl 40 stearate, purified water, sorbitan, monostearate, sorbitol solution, white petrolatum

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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: 2026-02-15T11:56:12.688694 · Updated: 2026-03-14T22:54:30.332332