GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [ABBE LABORATORIES, INC.]

GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [ABBE LABORATORIES, INC.]
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NDC 68605-2007-3, 68605-2007-4
Set ID b331c46d-855f-45f5-b3ee-3a611370face
Category HUMAN OTC DRUG LABEL
Packager ABBE Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • 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)

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