FDA.reportPublic FDA data

Calypxo HP Pain Relief

Manufacturer
Asclemed USA, Inc
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:48

Label at a glance#

ProductCalypxo HP Pain Relief
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………15.00%

Menthol……………………10.00%

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.
  • use with heating pad.
  • 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, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76420-999-01

Calypxo HP

Pain Relief Cream

4 oz (113g)

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN2
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD2
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY2
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-999-01Calypxo HP Pain Relief113 g in 1 BOTTLECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-999CALYPXO HP PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ASCLEMED USA, INC]2Current NDC, Legacy NDC, 1 package rows20231016_89a8c267-bd92-4d0d-8e50-c52224aff9cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-999-01GM - Gram76420-9994ed3fb4f-8734-4f72-a4de-01acff70ca7b12021-03-02

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-99976420-999-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
ndc (package): 76420-999-01
ndc (product): 76420-999
ndc11 (package): 76420099901
spl id: 07ceca92-2157-8829-e063-6294a90a8c97
spl set id: 89a8c267-bd92-4d0d-8e50-c52224aff9cd

Reported adverse events (FAERS/openFDA)#

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