CALYPXO PAIN RELIEF- methyl salicylate, menthol cream 
Asclemed USA, Inc

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Drugs Facts

Active Ingredients

Methyl Salicylate………10.00%

Menthol…………………3.00%

Purpose

Topical Analgesic

Topical Analgesic

Uses

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

Warning

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.

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

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

Directions

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

Additional Information

Store at room temperature.

Other Ingredients

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

NDC 76420-450-12

Calypxo

Pain Relief Cream

4 oz (113g)

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

image description

CALYPXO PAIN RELIEF 
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76420-450-12113 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/15/2014
Labeler - Asclemed USA, Inc (059888437)

Revised: 10/2023
Document Id: 07cec8ef-ecc9-ac49-e063-6294a90a6083
Set id: bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6
Version: 6
Effective Time: 20231016
 
Asclemed USA, Inc