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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Storage conditions

Store at a temperature below 30 ° C

Primary Package

Primary Package

Secondary Package

Secondary Package

AQUAX 
petrolatum, mineral oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM75 mg  in 150 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL75 mg  in 150 g
Inactive Ingredients
Ingredient NameStrength
CETEARETH-25 (UNII: 8FA93U5T67)  
CETEARETH-22 (UNII: 28VZG1E234)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82160-214-011 in 1 CARTON03/25/2010
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/2010
Labeler - Pella Pharmaceuticals Co. Ltd (562370925)

Revised: 11/2021
Document Id: d15eaed9-f0e7-65f1-e053-2995a90a774a
Set id: d15eaed9-f0e6-65f1-e053-2995a90a774a
Version: 214
Effective Time: 20211122
 
Pella Pharmaceuticals Co. Ltd