XtraCare Ice Cold Topical Analgesic Gel

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: XtraCare Ice Cold Topical Analgesic Gel
Generic name: MENTHOL
Manufacturer: Rejoice International
Product type: HUMAN OTC DRUG
SPL set ID: d38f3099-d940-44d8-aa7f-404157c5e0e3
SPL ID: 087f5ceb-0e96-0c3a-e063-6394a90acfc7
Version: 9
Effective date: 2023-10-24
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:53

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		XtraCare Ice Cold Topical Analgesic Gel	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Rejoice International	openfda.manufacturer_name
ndc	package	57337-052-01	openfda.package_ndc
ndc	package	57337-052-02	openfda.package_ndc
ndc	product	57337-052	openfda.product_ndc
ndc11	package	57337005202	derived:openfda.package_ndc
ndc11	package	57337005201	derived:openfda.package_ndc
rxcui		866128	openfda.rxcui
spl id		087f5ceb-0e96-0c3a-e063-6394a90acfc7	id
spl set id		d38f3099-d940-44d8-aa7f-404157c5e0e3	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

Warnings For external use only. Avoid contact with eyes. Ask a doctor before use if you have cough associated with smoking excessive phlegm asthma emphysema persistent or chronic cough When using this product do not heat microwave add to hot water or any container where heating water may cause splattering and result in burns use in eyes or directly on mucous membranes take by mouth or place in nostrils apply to wounds or damaged skin bandage skin Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Reported adverse events (FAERS/openFDA)#

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