FDA label 05ed1245-f8fd-45d1-85ad-5dad98bf568e

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)

SPL set ID: 5889aae9-6224-4cb1-a184-67a76597a48c
SPL ID: 05ed1245-f8fd-45d1-85ad-5dad98bf568e
Version: 1
Effective date: 2013-02-19
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:35:23

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		05ed1245-f8fd-45d1-85ad-5dad98bf568e	id
spl set id		5889aae9-6224-4cb1-a184-67a76597a48c	set_id

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

Warning Section WARNINGS: FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE PRODUCTS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE PRODUCT SHOULD BE USED UNLESS DIRECTED BY A HEALTH CARE PRACTITIONER. THIS PRODUCT CONTAINS AN ALPHAHYDROXY ACID (AHA) THAT MAY INCREASE YOUR SKINS SENSITIVITY TO THE SUN AND PARTICULARLY THE POSSIBILITY OF SUNBURN. PLEASE LIMIT SUN EXPOSURE AND APPLY SUNBURN PROTECTANT WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS. DO NOT USE IF TUBE SEAL HAS BEEN TAMPERED WITH.

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Report Adverse Section YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM THIS PRODUCT TO (USA) COVER FX 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 2919 (CANADA) COVER FX 1681 FLINT RD, TORONTO, ON M3J 2W8

Reported adverse events (FAERS/openFDA)#

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