AQUAX REPELLENT- ethyl butylacetylaminopropionate cream

Aquax Repellent by

Drug Labeling and Warnings

Aquax Repellent by is a Otc medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Forms and presentation

Cream: Tube of 75 g.

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.

Primary Package

Secondary Package

INGREDIENTS AND APPEARANCE

AQUAX REPELLENT 
ethyl butylacetylaminopropionate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH) (ETHYL BUTYLACETYLAMINOPROPIONATE - UNII:65GQA237EH)	ETHYL BUTYLACETYLAMINOPROPIONATE	75 mg  in 75 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-22 (UNII: 28VZG1E234)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-252-01	1 in 1 CARTON	10/04/2010
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/04/2010

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)