Capsaicin 0.05% Cream

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Capsaicin 0.05% Cream
Generic name
CAPSAICIN 0.05%
Manufacturer
Puretek Corporation
Product type
HUMAN OTC DRUG
SPL set ID
2cf17a28-711f-77bd-e063-6394a90a7061
SPL ID
2f3d2563-85c8-d5a3-e063-6294a90a6d3c
Version
2
Effective date
2025-02-28
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:16:11
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only • This is not a face cream. Do not apply to the face. • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. • Do not apply to wounds or damaged , broken, sunburned, chapped or irritated skin. • Do not bandage tightly. • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sentation. • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. if swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.