Aquax by Pella Pharmaceuticals Co. Ltd Aquax

Aquax by

Drug Labeling and Warnings

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

Drug Details [pdf]

AQUAX- petrolatum, mineral oil cream 
Pella Pharmaceuticals Co. Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Aquax

Forms and presentation

Cream: Tube of 150 g

Active Ingredients

Mineral Oil

Petrolatum

Inactive Ingredients

Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-22, Ceteareth-25, Polysorbate 80, Bis-PEG / PPG-16/16 PEG / PPG 16/16 Dimethicone; Caprylic/Capric Triglyceride, Sodium Citrate, Methylparaben, Citric Acid, Propylparaben.

Purpose

Moisturizer

Properties

Aquax ® Cream is an emollient and moisturizer that nourishes the skin.

Indications

Aquax ® Cream is used for dry and sensitive skin, in case of eczema and other similar skin problems; Aquax ® Cream helps prevent further water loss from the skin, preventing thereby skin dryness and reduces roughness, relieves itching and gives a sensation of comfort.

Contraindications

Hypersensitivity to any of the components.

Side effects

Aquax ® Cream has no known side effect, because using it is safe for all members of the Family, Children and Adults.

Dosage and Administration

Apply Aquax ® Cream on the skin and spread it well, it will help the skin to offset the loss of natural oils caused by washing, and prevents irritation that soap can cause to the skin.
Aquax ® Cream can be used as often as needed.

Precaution

Keep out of reach of children

Warnings

• For external use only
• If you are allergic to any of the ingredients, you should check with your doctor or pharmacist before you use the product.
• Avoid contact with eyes

Storage conditions

Store at a temperature below 30 ° C

Primary Package

Secondary Package

AQUAX 
petrolatum, mineral oil cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	7500 mg  in 150 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	7500 mg  in 150 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-22 (UNII: 28VZG1E234)
METHYLPARABEN (UNII: A2I8C7HI9T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARETH-25 (UNII: 8FA93U5T67)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-214-01	1 in 1 CARTON	03/25/2010
1		150 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		03/25/2010	01/22/2025

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)

Revised: 1/2025

Document Id: 2c3489aa-6690-2ea9-e063-6294a90ab012

34390-5

Set id: d15eaed9-f0e6-65f1-e053-2995a90a774a

Version: 217

Effective Time: 20250121