FDA label 98447f75-5077-413f-8b86-8814487e295f

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
afccb9d4-8a21-4a12-9161-f9b51e70d03e
SPL ID
98447f75-5077-413f-8b86-8814487e295f
Version
4
Effective date
2016-08-09
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 01:25:38

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 Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing, as severe asthma attack in certain susceptible persons. Do not use on children under 12 years of age unless directed by a doctor. When using this product avoid contact with eyes some users may experience a mild skin irritation Stop use and ask a doctor if skin irritation becomes severe or allergic reactions occurs such as hives, itching or wheezing Sunburn alert: This product 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 and for a week afterwards. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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