CalaSoothe

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)

Brand name
CalaSoothe
Generic name
CALAMINE, MENTHOL, AND ZINC OXIDE
Manufacturer
Dynarex Corporation
Product type
HUMAN OTC DRUG
SPL set ID
54f12005-acfe-4821-e063-6394a90ac304
SPL ID
54f12005-acff-4821-e063-6394a90ac304
Version
1
Effective date
2026-06-24
Source export date
2026-09-28
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:40:31
Harmonized routes table
Harmonized routes
TOPICAL

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 Stop use and ask a doctor if • condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases When using this product • Do not exceed the recommended daily dosage unless directed by a doctor • Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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