Biofreeze Overnight Roll-on

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
Biofreeze Overnight Roll-on
Generic name
MENTHOL
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
SPL set ID
f67d7b7a-8922-73f6-e053-2995a90a2e80
SPL ID
51e06d5e-11fe-5814-e063-6294a90a2736
Version
3
Effective date
2026-05-15
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 06:27:33
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Flammable: Keep away from excessive heat or open flame When using this product: ■use only as directed ■avoid contact with the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not apply to irritated skin or if excessive irritation develops ■do not bandage tightly or use with heating pad or device ■children 2 years to under 12 years of age: use only under adult supervision Stop use and ask a doctor if: ■ you experience pain, swelling or blistering of the skin ■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breast-feeding: ■ ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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