Label: AQUAGARD- hydrating ointment ointment

  • NDC Code(s): 67777-014-03, 67777-014-04, 67777-014-05, 67777-014-63, view more
    67777-014-64, 67777-014-65
  • Packager: Dynarex Corporation
  • 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 December 1, 2022

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  • Active ingredient

    Petrolatum 41%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor cuts, scrapes, burns
    • Temporarily protects and helps relieve dry, chapped, or cracked skin and lips
    • Helps protect skin from the drying effects of wind and cold weather
  • Warnings

    For External Use Only

    Avoid contact with eyes. In case of contact, flush thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use

    on deep puncture wounds, animal bites, or serious burns.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed or as directed by a physician.

  • Other Information

    Store at room temperature (59°-86°F).

  • Inactive ingredients

    Ceresin Wax, Dexpanthenol, Glycerin, Lanoline Alcohol, Mineral Oil

  • Questions?

    1-888-DYNAREX Monday-Friday, 9AM-5PM EST

  • Label

    1463 Principal Display Panel

  • Label

    1464 IN MASTER

  • Label

    1465 DM MASTER1465 BX MASTER

  • INGREDIENTS AND APPEARANCE
    AQUAGARD 
    hydrating ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-014-6324 in 1 CASE12/20/2019
    1NDC:67777-014-03106 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-014-6412 in 1 CASE12/20/2019
    2NDC:67777-014-04396.9 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:67777-014-6512 in 1 CASE12/20/2019
    3NDC:67777-014-05144 in 1 BOX
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/20/2019
    Labeler - Dynarex Corporation (008124539)
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