Zpol Ultra

Zpol Ultra
SPL v3
SPL
SPL Set ID 1a1433a6-8d04-96df-e063-6394a90a987b
Route
TOPICAL
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.84 g) Salicylic Acid (18.24 g)
Inactive Ingredients
Sorbitan Tristearate Carbomer Cetearyl Alcohol Glyceryl Stearate Peg-40 Stearate Ceteareth-20 Eucalyptol Polysorbate 20 Triethanolamine Thymol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Menthol 4%Methyl Salicylate 10%

Purpose

Active Ingredients Purpose Menthol 2.84% Topical Analgesic Methyl salicylate 18.24% Topical Analgesic


Medication Information

Purpose
Active Ingredients Purpose
Menthol 2.84% Topical Analgesic
Methyl salicylate 18.24% Topical Analgesic

Description

Menthol 4%Methyl Salicylate 10%

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.

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.

Questions?

Call toll free +506 (800)-937-6572 [email protected]

Other Information

Store between 20-25°C (68-77°F).

Active Ingredients

Menthol 4%Methyl Salicylate 10%

Zpol Ultra 4.02 Oz

NDC 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB

Zpol Ultra 1.02 Oz

NDC 55715-008-01

zpol ULTRA

MUSCULAR Topical analgesic cream

Net wt. 1.02 Oz

ZepoLAB

Manufactured by

Laboratorios Zepol, S.A.

Curridabat, San José,

Costa Rica, 11801

Product of Costa Rica

IN COSTA RICA CALL FRO FREE 800-937-6572

(800-SZEPOLSA)

Regional Customer Service:

[email protected]

www.zepolab.com

Tamper Evident: Do not use if seal undercap is broken or missing

EXTERNAL USE/OVER THE COUNTER Zpol ULTRA Cream

is a medicated cream, due to its components and texture it is recommended for the relief of muscle pain, bumps, sprains and sports injuries. It also relieves arthritic and rheumatic pain.

Zpol Ultra 2.08 Oz

NDC 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

Inactive Ingredients

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

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.


Structured Label Content

Uses

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

Purpose
Active Ingredients Purpose
Menthol 2.84% Topical Analgesic
Methyl salicylate 18.24% Topical Analgesic

Warnings

For external use only.

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.

Questions?

Call toll free +506 (800)-937-6572 [email protected]

Other Information (Other information)

Store between 20-25°C (68-77°F).

Active Ingredients (Active ingredients)

Menthol 4%Methyl Salicylate 10%

Zpol Ultra 4.02 Oz (Zpol ULTRA 4.02 Oz)

NDC 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB

Zpol Ultra 1.02 Oz (zpol ULTRA 1.02 Oz)

NDC 55715-008-01

zpol ULTRA

MUSCULAR Topical analgesic cream

Net wt. 1.02 Oz

ZepoLAB

Manufactured by

Laboratorios Zepol, S.A.

Curridabat, San José,

Costa Rica, 11801

Product of Costa Rica

IN COSTA RICA CALL FRO FREE 800-937-6572

(800-SZEPOLSA)

Regional Customer Service:

[email protected]

www.zepolab.com

Tamper Evident: Do not use if seal undercap is broken or missing

EXTERNAL USE/OVER THE COUNTER Zpol ULTRA Cream

is a medicated cream, due to its components and texture it is recommended for the relief of muscle pain, bumps, sprains and sports injuries. It also relieves arthritic and rheumatic pain.

Zpol Ultra 2.08 Oz (zpol ULTRA 2.08 Oz)

NDC 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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 (If pregnant or breast-feeding)

, ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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