FDA.reportPublic FDA data

ACNE

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
ACNE
Generic name
NICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.
Manufacturer
PLYMOUTH HEALTHCARE PRODUCTS LLC
Product type
HUMAN OTC DRUG
SPL set ID
6cdd54fa-6997-48da-8209-86e530f83c61
SPL ID
440c7914-10ad-4966-e063-6394a90a013b
Version
7
Effective date
2025-11-20
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:21
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings: DO NOT USE if you have kidney disease in children under 10 years old children under 50 lbs if pregnant Ask a doctor before use if you have a known sensitivity to nickel or costume jewelry a known sensitivity to any ingredients in this product Stop use and ask a doctor if skin rash appears feelings of nervousness occur if condition worsens or does not improve after regular use of this product ​If pregnant, ​​do not use. ​ If breast-feeding , ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

warnings table

<table width="873px"><caption>Warnings: </caption><tbody><tr><td><paragraph><content styleCode="bold">DO NOT USE</content></paragraph><list listType="unordered"><item>if you have kidney disease</item><item>in children under 10 years old</item><item>children under 50 lbs</item><item>if pregnant</item></list></td></tr><tr><td><paragraph><content styleCode="bold">Ask a doctor before use if</content></paragraph><list listType="unordered"><item>you have a known sensitivity to nickel or costume jewelry</item><item>a known sensitivity to any ingredients in this product</item></list></td></tr><tr><td/></tr><tr><td><paragraph><content styleCode="bold">Stop use and ask a doctor if</content></paragraph><list listType="unordered"><item>skin rash appears</item><item>feelings of nervousness occur</item><item>if condition worsens or does not improve after regular use of this product</item></list><paragraph><content styleCode="bold">&#x200B;If pregnant,</content> &#x200B;&#x200B;do not use. <content styleCode="bold"/>&#x200B; </paragraph><paragraph/></td></tr><tr><td><paragraph><content styleCode="bold"> If breast-feeding</content>, ask a doctor before use. </paragraph><paragraph><content styleCode="bold">Keep out of reach of children.</content>In case of overdose, get medical help or contact a Poison Control Center right away. </paragraph></td></tr><tr><td/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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