ZPOL ULTRA- menthol, methyl salicylate cream

Zpol ULTRA by

Drug Labeling and Warnings

Zpol ULTRA by is a Otc medication manufactured, distributed, or labeled by Laboratorios Zepol S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 4%Methyl Salicylate 10%

Purpose

• Active Ingredients: Purpose
• 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 ULTRA 2.08 Oz

NDC: 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

Zpol ULTRA 4.02 Oz

NDC: 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB

INGREDIENTS AND APPEARANCE

ZPOL ULTRA 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55715-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.84 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	18.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55715-008-01	29 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2024
2	NDC: 55715-008-02	59 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2024
3	NDC: 55715-008-03	119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/04/2024

Labeler - Laboratorios Zepol S.A. (853070985)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Zepol S.A.		853070985	manufacture(55715-008)