FDA.reportPublic FDA data

PainXIT

Manufacturer
Asclemed USA, Inc
Effective date
2022-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:45

Label at a glance#

ProductPainXIT
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Dosage and administration

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drugs Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate………10.00%

Menthol…………………3.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Warning

WARNINGS SECTION

For external use only.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or cover treated areas.

Do not use with heating pad.

Do not apply to open wounds or damages skin.

A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.

If symptoms persist for more than seven days, discontinue use and consult physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, consult physician.

If pregnant or breast feeding, contact physician prior to use.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Additional Information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76420-211-01

PainXIT

Pain Relief Cream

4 oz (113.4g)

Distributed by:
Enovachem
PHARMACEUTICALS
Torrance, CA 90501
(310) 320-0100

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-21176420-211-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TROLAMINE9O3K93S3TKIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB

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
07066a40-7d76-6ec5-e063-6294a90ac6bad356a001-372f-430e-9a75-4657ea36fdde2023-10-06WarningsExact identifier
spl set id: d356a001-372f-430e-9a75-4657ea36fdde

Reported adverse events (FAERS/openFDA)#

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