Calypxo Pain Relief

Manufacturer: Asclemed USA, Inc
Effective date: 2023-10-16
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 23:56:48

Label at a glance#

ProductCalypxo 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.

Contacts and useful links#

PhoneLabel contact(310) 320-0100

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

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 76420-450-12

Calypxo

Pain Relief Cream

4 oz (113g)

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

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	PSN	6
1486874	menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	6
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-450-12	Calypxo Pain Relief	113 g in 1 BOTTLE	CREAM	113		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-450	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ASCLEMED USA, INC]	6	Current NDC, Legacy NDC, 1 package rows	20231016_bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-450-12	GM - Gram	76420-450	e387b485-2d49-4f5c-bfa1-3c2fa94acbe0	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	2
Methyl Salicylate	ACTIVE INGREDIENT	LAV5U5022Y	2
Menthol	ACTIVE MOIETY	L7T10EIP3A	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	2
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	2
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	2
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	2
MethylParaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
PropylParaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Sodium lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Calypxo Pain Relief
Methyl Salicylate, Menthol
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALOE VERA LEAF
WATER
CETYL ALCOHOL
DIAZOLIDINYL UREA
ISOPROPYL MYRISTATE
METHYLPARABEN
POLYETHYLENE GLYCOL 400
PROPYLPARABEN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
TROLAMINE
METHYL SALICYLATE
SALICYLIC ACID
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76420-450	76420-450-12

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
Name	UNII	Kind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TROLAMINE	9O3K93S3TK	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MethylParaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MethylParaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PropylParaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sodium lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sodium lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PropylParaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	2023-10-16	Warnings	Exact identifier ndc (package): 76420-450-12 ndc (product): 76420-450 ndc11 (package): 76420045012 spl id: 07cec8ef-ecc9-ac49-e063-6294a90a6083 spl set id: bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6

Reported adverse events (FAERS/openFDA)#

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