Label: GRANDMA ELS- diaper rash ointment ointment

  • NDC Code(s): 68605-2007-3, 68605-2007-4
  • Packager: ABBE Laboratories, Inc.
  • 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 January 14, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active Ingredients
    Amber Petroluatum 75.95%...........
    Lanolin 15.50%..............................

  • PURPOSE

    Purpose
    .......Protectant, Emollient
    .......Protectant, Emollient

  • INDICATIONS & USAGE

    Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness

  • WARNINGS

    Warnings:
    For external use only

  • WHEN USING

    When using this product • do not get into eyes

  • STOP USE

    Stop use and ask a doctor if • condition worsens • symtoms last more than 7 day or clear up and occur again within a few days

  • DO NOT USE

    Do not use on • deep or puncture wounds • animal bites • serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

  • DOSAGE & ADMINISTRATION

    Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.

  • OTHER SAFETY INFORMATION

    Other Information: Store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Other Ingredients:
    Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)

  • QUESTIONS

    For Questions call (800) 457-0990 Mon-Fri

  • SPL UNCLASSIFIED SECTION

    Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

    www.GrandmaEls.com

  • ———PACKAGE LABEL.PRINCIPAL DISPLY PANEL———

    Warnings continued: Do not use on: • deep or puncture

    wounds • animals bites • serious burns

    Keep out of reach of children.  If swallowed, get

    medical help or contact a Poison Control Center

    Directions: Change wet and soiled diapers promptly.

    Cleans diaper area and allow to dry.  Apply a thin film of

    ointment to entire diaper area with every diaper change.

    Other Information: Store at 20° to 25°C (68° to 77°F)

    Other Ingredients: 

    Tocopherol Acetate (Vitamin E), Cetyl Esters,

    Ethyl Methylphenylglycidate, Benzyl Cinnamate

    (extracts of balsam of peru)

    For Questions call (800) 457-0990 Mon-Fri

    Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

    wwwGrandmaEls.com

    Creates a

    Breathable Barrier

    Use with Every

    Diaper Change

    Soothes, Calms

    + Heals

    NET WT 3.75 OZ.

    GRANDMA EL'S

    Diaper Rash Ointment

    Made in the USA

    Pediatrician Recommended

    DOES NOT CONTAIN

    PARABENS,

    PHTHALATES OR SLS

    DRUG FACTS:

    Active Ingredients                        Purpose

    Amber Petrolatum 75.95%..........Protectant, Emollient

    Lanolin USP 15.50%...................Protectant, Emollient

    Uses: Helps treat and prevent diaper rash

    • Protects and heals chafed and irritated skin
    • Provides barrier to seal out wetness

    Warnings:

    For external use only

    When using this product • do not get into eyes

    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

    2001-16

    3 52248 00001 5

    Product Label
  • INGREDIENTS AND APPEARANCE
    GRANDMA ELS 
    diaper rash ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68605-2007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.7595 g  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.155 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68605-2007-356.7 g in 1 TUBE; Type 0: Not a Combination Product02/01/2015
    2NDC:68605-2007-4106.3 g in 1 JAR; Type 0: Not a Combination Product02/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2015
    Labeler - ABBE Laboratories, Inc. (781745286)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABBE Laboratories, Inc.781745286manufacture(68605-2007)