FDA.reportPublic FDA data

NOPEN HOT

Manufacturer
JW HOLDINGS CORPORATION
Effective date
2018-08-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:52:40

Label at a glance#

ProductNOPEN HOT
Active ingredientMENTHOL, UNSPECIFIED FORM, GLYCOL SALICYLATE
Label structure9 sections

Indications and uses

Temporary relieves mild to moderate aches and pains of muscles and joints associated with: ■simple backache ■bruises ■sprains ■shoulder pains ■muscle pains ■arthritis

Dosage and administration

■ clean and dry affected area before applying ■ peel off protective backing and apply sticky side to affected area and leave in place for up to 8 to 12 hours ■ remove used patch from skin before applying a new patch

Label contents#

Full prescribing information#

Active Ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Glycol Salicylate 35mg

L-Menthol 35mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relieves mild to moderate aches and pains of muscles and joints associated with:

■simple backache ■bruises ■sprains ■shoulder pains ■muscle pains ■arthritis

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■on the face or rashes ■wounds or damaged skin ■with a heating pad

■if you are allergic to salicylates ■when sweating (Such as from exercise or heat)

■on children under 12 years of age

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ you have redness over the affected area ■ pregnant or breast feeding

When using this product

OTC - WHEN USING SECTION

■ wash hands after applying or removing patch. ■ avoid contact with eyes or mucous membranes. ■ if eye contact occurs, rinse thoroughly with water ■ do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ rash, itching or skin irritation develops ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Package not child-resistant. Dispose of the used patches after folding sticky ends together. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ clean and dry affected area before applying

■ peel off protective backing and apply sticky side to affected area and leave in place for up to 8 to 12 hours

■ remove used patch from skin before applying a new patch

Other information

OTHER SAFETY INFORMATION

■ store at 20℃ to 25℃ (68℉ to 77℉)

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

■ some individuals may not experience pain relief until several hours after applying the patch

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acryl Adhesive, Capsicum Tincture, Nonwoven Polyester Fabric, Paper Release Liner, Rubber Adhesive, Vanillyl Butyl Ether

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-562-281-5888 Monday-Friday 9AM-4PM ET

Distributed by: Jemian USA Inc

Principal Display Panel- 5 Patches

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JW Pharmaceutical

NOPEN

Hot

Hot sensation type Glycol Salicylate/L-Menthol/Capsicum Tincture

5 Patches

2.7 in x 3.9 in (7 x 10 cm)

NOPEN Hot PatchNOPEN Hot Patch

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69365-00569365-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLYL BUTYL ETHERS2ULN37C9RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
GLYCOL SALICYLATE3I1VBB7AXHACTIB
LOW DENSITY POLYETHYLENEJ245LN42AIIACT
POWDERED CELLULOSESMD1X3XO9MIACT
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00)645M2T7FHZIACT
CAPSICUM00UK7646FGIACT
2-ETHYLHEXYL ACRYLATEHR49R9S6XGIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
73da2dad-c94e-f85f-e053-2991aa0a176f54b9d276-4ff2-2cc2-e054-00144ff8d46c2018-08-20WarningsExact identifier
spl id: 73da2dad-c94e-f85f-e053-2991aa0a176f
spl set id: 54b9d276-4ff2-2cc2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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