CALYPXO PAIN RELIEF- methyl salicylate, menthol cream 
Advanced Rx Pharmacy of Tennessee, LLC

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Calypxo Cream

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

Calypxo Cream 1

CALYPXO PAIN RELIEF 
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0369(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:80425-0369-1113 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/01/2023
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0369)

Revised: 12/2023
Document Id: 0b7706f0-eb84-5bce-e063-6294a90a4048
Set id: 0b7736df-c7e0-7d00-e063-6294a90aa57e
Version: 1
Effective Time: 20231201
 
Advanced Rx Pharmacy of Tennessee, LLC