FDA label c161f48d-345d-4e36-bc4d-b616ffaf8aae

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
f2001803-be47-42a1-8509-57cd89b4a7d4
SPL ID
c161f48d-345d-4e36-bc4d-b616ffaf8aae
Version
1
Effective date
2017-07-24
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 23:11:51

Warnings cross-check#

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

Warnings sections page 1 of 1 · 4 matching rows.

warnings

Warnings For external use only When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor Do not use on broken skin large areas of the skin When using this product apply only to areas with acne Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings For external use only. Do not swallow. If product is swallowed, get medical help or contact a Poison Control Centre right away. Keep entirely clear of eye area. If product enters eye, rinse with water. If irritation or rash occur, discontinue use and consult your doctor. Keep out of reach of children. Use only as directed. It is recommended that prior to exposure to the sun, users cover areas where alpha-hydroxy acids (AHAs) have been applied with sunscreen. Contact of the product with the skin must be of limited frequency and duration.

warnings

Warnings For external use only Do not use if you have very sensitive skin are sensitive to benzoyl peroxide When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

warnings

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.