ZPOL ULTRA- menthol, methyl salicylate cream 
Laboratorios Zepol S.A.

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Zpol Ultra

Drug Facts

Active ingredients

Menthol 4%Methyl Salicylate 10%

Purpose

Active IngredientsPurpose
Menthol 2.84%Topical Analgesic
Methyl salicylate 18.24%Topical Analgesic

Uses

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

Warnings

For external use only.

When using this product

Do not apply to wounds or damaged skin

Do not bandage tightly

Avoid contact with eyes

Do not use with a heating pad

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding

, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult a doctor.

Other information

Store between 20-25°C (68-77°F). Tamper Evident: Do not use it seal under cap is broken or missing

Inactive ingredients

Allantoin, benzoic acid, cetearyl alcohol, cetearyl glucoside, pheonoxyethanol, stearic acid, water.

Questions?

Call toll free +506 (800)-937-6572 laboratorioszepol@zepolab.com

zpol ULTRA 1.02 Oz

NDC 55715-008-01

zpol ULTRA

Topical analgesic cream

1.02 Oz

ZepoLAB

Zpol 1.02 Oz

zpol ULTRA 2.08 Oz

NDC 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

Zpol 2.08 Oz

Zpol ULTRA 4.02 Oz

NDC 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB

Zpol 4.02 Oz

ZPOL ULTRA 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.84 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALLANTOIN (UNII: 344S277G0Z)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55715-008-0129 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
2NDC:55715-008-0259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
3NDC:55715-008-03119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/04/2024
Labeler - Laboratorios Zepol S.A. (853070985)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Zepol S.A.853070985manufacture(55715-008)

Revised: 6/2024
Document Id: 1adfb1e2-f37f-c976-e063-6294a90a4cbd
Set id: 1a1433a6-8d04-96df-e063-6394a90a987b
Version: 2
Effective Time: 20240614
 
Laboratorios Zepol S.A.