Forms And Presentation
Cream: Tube of 75 g.
Aquax Repellent
FDA Label NDC 82160-252
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Aquax Repellent (NDC 82160-252). 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 forms and presentation, active ingredient, inactive ingredients, purpose, properties, indications, precautions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Butylacetylaminopropionate
Inactive Ingredients
Aqua, Cetearyl Alcohol, Ceteareth-22, Petrolatum, Ceteareth-25, Glycerin, Polysorbate 80, Bis-PEG/ PPG-16/16 PEG/ PPG 16/16 Dimethicone; Caprylic/Capric Triglyceride, Sodium Phosphate, Disodium Phosphate, Methylparaben, Propylparaben and BHA.
Purpose
Insect repellent
Properties
Aquax ® Repellent Cream is a cream that hydrates, nourishes, and expels the pesky insects.
Indications
Aquax ® Repellent Cream hydrates the skin, decreases itchy sensation and provides the feeling of comfort. It's characterized by the presence of the active ingredient Ethyl Butylacetylaminopropionate (IR3535) that acts as a bio-pesticide, its efficacy as insect repellent endures for 6 hours long.
Precautions
Keep out of reach of children
Warnings
- For external use only.
- Do not apply to eyes or mouth, and apply sparingly around ears.
- Do not allow use by small children without adult supervision.
- Never use repellent over cuts, wounds or irritated skin.
- If you are allergic to any of the ingredients listed, you should check with your doctor or pharmacist before you use the product
Contraindications
Hypersensitivity to any of the components.
Side Effects
Aquax
® Repellent Cream has no known side effect, because its use is safe.
Preferably used by small children under the supervision of an adult.
Dosage And Administration
Apply just enough Aquax ® Repellent Cream to cover exposed skin.
Storage Conditions
Store at a temperature below 30° C.
* Please review the disclaimer below.
