FDA label b9b1f566-ab1a-442b-b79f-5543f99927e5

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
ac3ddbce-e2e2-4e32-ba19-ae080bf8d416
SPL ID
b9b1f566-ab1a-442b-b79f-5543f99927e5
Version
1
Effective date
2018-05-18
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:35:52

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.