Dermachange Cold Therapy

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: Dermachange Cold Therapy
Generic name: MENTHOL
Manufacturer: Private Label Beauty and Wellness
Product type: HUMAN OTC DRUG
SPL set ID: 12ef7dd8-3da3-9c87-e063-6394a90ac924
SPL ID: 12ef7dd8-3da2-9c87-e063-6394a90ac924
Version: 1
Effective date: 2024-03-05
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:31

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Dermachange Cold Therapy	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Private Label Beauty and Wellness	openfda.manufacturer_name
ndc	package	83520-131-08	openfda.package_ndc
ndc	product	83520-131	openfda.product_ndc
ndc11	package	83520013108	derived:openfda.package_ndc
rxcui		311502	openfda.rxcui
spl id		12ef7dd8-3da2-9c87-e063-6394a90ac924	id
spl set id		12ef7dd8-3da3-9c87-e063-6394a90ac924	set_id
unii		L7T10EIP3A	openfda.unii

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

For external use only. Do not use with other topical pain relievers, with heating pad or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

Reported adverse events (FAERS/openFDA)#

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