Label: AQUAX- petrolatum, mineral oil cream

  • NDC Code(s): 82160-214-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 22, 2021

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  • 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

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    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)
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