Capsaicin 0.1% Cream

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

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

Brand name
Capsaicin 0.1% Cream
Generic name
CAPSAICIN 0.1%
Manufacturer
Puretek Corporation
Product type
HUMAN OTC DRUG
SPL set ID
4e83441b-cb6a-beb0-e063-6394a90a1b54
SPL ID
4e83442a-1ace-3a67-e063-6294a90a93df
Version
1
Effective date
2026-04-03
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:10:54
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 cause a burning sensation. • Do not use with a 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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor. 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.