436eac74-d07f-d718-e063-6394a90a8660

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
Purpose

Topical Analgesic

Description

Capsaicin 0.025%

Medication Information

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.

Uses

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

Purpose

Topical Analgesic

Directions

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

Inactive Ingredients

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

Description

Capsaicin 0.025%

Storage

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

Drug Facts

Active Ingredient

Capsaicin 0.025%

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

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.

Uses (USES)

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

Purpose (PURPOSE)

Topical Analgesic

Directions (DIRECTIONS)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Storage (STORAGE)

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

Drug Facts (DRUG FACTS)

Active Ingredient (ACTIVE INGREDIENT)

Capsaicin 0.025%

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