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  5. Label Information: Zpol Ultra

FDA Label for Zpol Ultra

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zpol Ultra Product Label

The following document was submitted to the FDA by the labeler of this product Laboratorios Zepol S.a.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 [email protected]


Package Label.Principal Display Panel



NDC 55715-008-01

zpol ULTRA

Topical analgesic cream

1.09 Oz

ZepoLAB

NDC 55715-008-02

zpol ULTRA

Topical analgesic cream

2.08 Oz

ZepoLAB

NDC 55715-008-03

zpol ULTRA

Topical analgesic cream

4.02 Oz

ZepoLAB


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