FDA label fabce85e-43e6-4b04-8341-b702fd35214e

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
d5693b98-6fb6-42f0-b01e-b5c2651d1420
SPL ID
fabce85e-43e6-4b04-8341-b702fd35214e
Version
2
Effective date
2014-09-11
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:48

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings For external use only. Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness, or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise. When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product. Stop use and ask a doctor if excessive irritation occurs. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

warnings

Warnings For external use only. Do not use • If you have a known allergy to Salicylic Acid or aspirin. When using this product • with other topical acne medications at the same time or immediately following use of the product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor. • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • If you have aspirin sensitivity, consult a physician prior to use. Stop use and ask a doctor • if excessive irritation occurs. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

warnings

Warning: For external use only.

Reported adverse events (FAERS/openFDA)#

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