FDA.reportPublic FDA data

GAMER-X

Manufacturer
Asclemed USA, Inc.
Effective date
2022-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:52:38

Label at a glance#

ProductWasabi Rub
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure8 sections

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20.00%

Menthol 10.00%

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Topical Analgesic

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - ASK DOCTOR SECTION

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.

OTC - DO NOT USE SECTION

Do not apply on damaged or broken skin. Do not bandage tightly.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Additional Information

OTHER SAFETY INFORMATION

Store at room temperature.

Other Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Carbomer, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD&C Blue#1 and FD&C Yellow#5.

Principal Display Panel - Wasabi Rub Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wasabi Rub  TM

Pain Relief 
Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Principal Display Panel - Wasabi Rub Label
Principal Display Panel - Wasabi Rub Label

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-20176420-201-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PEG-100 STEARATEYD01N1999RIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

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
070662e8-3327-d916-e063-6394a90a825cb2ef3215-2b82-47da-892f-dc9d3a53e9852023-10-06WarningsExact identifier
spl set id: b2ef3215-2b82-47da-892f-dc9d3a53e985

Reported adverse events (FAERS/openFDA)#

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