FDA label 7e3354b4-6202-423f-bb85-88c0ac01958d

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
5d185f23-8af6-4e36-b514-5662986520a5
SPL ID
7e3354b4-6202-423f-bb85-88c0ac01958d
Version
1
Effective date
2022-07-11
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:13

Warnings cross-check#

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

Warnings sections page 1 of 4 · 13 matching rows.

warnings

WARNING For external use only. Do not use in the eyes over large areas of the body or on deep puncture wounds, animal bites, or serious burns in large quantities, particularly over raw surfaces or blistered areas Stop use and ask doctor if the condition gets worse condition clears up and recurs within a few days condition persists for more than 7 days If pregnant or breast feeding, ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

WARNING For external use only Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

warnings

WARNING For external use only avoid contact with the eyes if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor do not use for the treatment of diaper rash. Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away.

warnings

METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy ALLERGY ALERT do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics. Do not use For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product avoid contact with eyes. If it occurs, flush with water. Do not exceed recommended dosage. If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding,ask a health care professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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