FDA label 5f89b9f3-7a29-3109-e053-2991aa0a3a2f

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
79a18783-6885-469f-bb16-b1d5e2812001
SPL ID
5f89b9f3-7a29-3109-e053-2991aa0a3a2f
Version
3
Effective date
2017-12-04
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:12

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

Warnings For external use only. Flammable. Keep away from fire or flame. ​Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body Ask a doctor before use • on chicken pox • on measles ​When using this product ​ • avoid contact with eyes Stop use and ask a doctor if • condition worsens or does not improve within 7 days • symptoms persist more than 7 days or clear up and occur again within a few days Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away Directions • do not use more than directed • ​adults and children 2 years of age and older: ​ apply to affected area not more than 3 to 4 times daily • ​children under 2 years of age: ​ask a doctor

Reported adverse events (FAERS/openFDA)#

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