FDA label adb9401a-fea0-4a65-bb9e-61b3071250bd

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
fa38ccee-4244-4a16-999c-2ea7476e009f
SPL ID
adb9401a-fea0-4a65-bb9e-61b3071250bd
Version
3
Effective date
2014-12-04
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:56

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

For external use only. Avoid use in the following cases: 1) people who are allergic to any of the listed ingredient(s), 2) around the eye area and/or mucous membrane, 3) presence of infecton, inflammation, flares and/or sensitivity. Using along with other acne products may increase the possibility of experiencing skin dryness/irritation. Avoid contact on eye and lip areas as well as around mucous membrane. If in contact, wash off with ample amount of water and follow doctor’s instructions on severe cases. Store it in a cool, dry place (below 122°F/50°C), away from direct sunlight. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Use on toddlers is prohibited. This product contains Salicylic Acid and is not to be used for children under 3 years. This product contains Salicylic Acid that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product. Consumers with known bee allergies should NOT use this product as beeswax & bee venom may induce allergic response(s).

Reported adverse events (FAERS/openFDA)#

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