TheraCare Roll-on Menthol 4% Pain Relief

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
TheraCare Roll-on Menthol 4% Pain Relief
Generic name
MENTHOL
Manufacturer
Veridian Healthcare
Product type
HUMAN OTC DRUG
SPL set ID
fa121e5f-94b5-4c1d-9c4e-85bb8ede3945
SPL ID
3f694987-bd01-d332-e063-6294a90a5b1f
Version
1
Effective date
2025-09-22
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:45
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 When using this product When using this product ■ use only as directed. Read and follow all directions and warnings on this carton ■ rare cases of serious burns have been reported with products of this type ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ avoid contact with eyes and mucous membranes ■ do not apply to wounds or damaged, broken or irritated skin ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with the product to heat or direct sunlight ■ avoid applying into skin folds Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied Flammable ■ Keep away from fire or flame 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.