Active Ingredients
Menthol 4%Methyl Salicylate 10%
Zpol Ultra Cream
FDA Label NDC 55715-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Zepol S.a. for the product Zpol Ultra (NDC 55715-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 [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
* Please review the disclaimer below.
