SPL v3
SPL
SPL Set ID 436eac74-d07f-d718-e063-6394a90a8660
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Coconut Oil

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-12
Description

Capsaicin 0.025%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.025%

Uses

For temporary relief of minors aches and pain associated with Arthritis, Back Pain,Muscle Aches, Strains, Sprains, Cramps.

Storage

Store at room temperature (68° to 77° F) Product liquifies at 76° F

Warnings

For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to wounds or damaged skin. Do not bandage tightly and avoid direct heat (heating pads) or sunlight. Do not use at the same time as other topical analgesics. For children 12 years of age and younger consult with a physician before use.

Directions

Adults and Children 12 years and older, apply to affected areas no more than 3 to 4 times daily.

Drug Facts

Active Ingredient

Capsaicin 0.025%

Inactive Ingredients

Coconut oil, Chilli peppers, Arnica, Green tea, Rooibos tea, Nettle, Calendula,Ginger, Peppermint, Chamomile, Carrot seed, Menthol.

Keep Out of Reach of Children.

For Children 12 yearsof ge and younger consult with a physician before use.

Stop Use and Consult A Doctor If

Pregnant or Breast Feeding. Allergic to Chilli peppers or Capsaicin. Severe Burning or Blistering Occurs.

Questions? Or for More Information: Call Us At

1(541) 673-2188

Structured Label Content

Uses (USES)

For temporary relief of minors aches and pain associated with Arthritis, Back Pain,Muscle Aches, Strains, Sprains, Cramps.

Purpose (PURPOSE)

Topical Analgesic

Storage (STORAGE)

Store at room temperature (68° to 77° F) Product liquifies at 76° F

Warnings (WARNINGS)

For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to wounds or damaged skin. Do not bandage tightly and avoid direct heat (heating pads) or sunlight. Do not use at the same time as other topical analgesics. For children 12 years of age and younger consult with a physician before use.

Directions (DIRECTIONS)

Adults and Children 12 years and older, apply to affected areas no more than 3 to 4 times daily.

Drug Facts (DRUG FACTS)

Active Ingredient (ACTIVE INGREDIENT)

Capsaicin 0.025%

Inactive Ingredients (INACTIVE INGREDIENTS)

Coconut oil, Chilli peppers, Arnica, Green tea, Rooibos tea, Nettle, Calendula,Ginger, Peppermint, Chamomile, Carrot seed, Menthol.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

For Children 12 yearsof ge and younger consult with a physician before use.

Stop Use and Consult A Doctor If (STOP USE AND CONSULT A DOCTOR IF)

Pregnant or Breast Feeding. Allergic to Chilli peppers or Capsaicin. Severe Burning or Blistering Occurs.

Questions? Or for More Information: Call Us At (QUESTIONS? OR FOR MORE INFORMATION: CALL US AT)

1(541) 673-2188

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:32.190810 · Updated: 2026-03-14T23:12:47.494493