GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [MEADOWBROOK LABS, INC.]

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GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [MEADOWBROOK LABS, INC.]
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NDC 52248-200-41, 52248-200-42, 52248-200-43
Set ID 7dc80455-a326-478c-8b3a-1f38f31fd97c
Category HUMAN OTC DRUG LABEL
Packager MEADOWBROOK LABS, INC.
Generic Name
Product Class
Product Number
Application Number PART347
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  • DRUG FACTS:                                       NDC #52248-200-41

  • 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 • Helps alleviate pain, itching and redness associated with diaper rash

  • 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)
                                     May stain clothing

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    For Questions call (800) 493-0223 Mon-Fri

  • SPL UNCLASSIFIED SECTION

    Works with most cloth diapers
    please contact your diaper manufacturer
    Mfd for Meadowbrook Labs, Inc., Farmingdale, NY

    DOES NOT CONTAIN PARABENS, PHTHALATES, OR SLS.

    www.GrandmaEls.com

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

    GRANDMA EL'S

    Diaper Rash
    Ointment

    Pediatrician
    Recommended

    Prevent • Protect • Treat

    Made in the USA
    NET WT. 2 OZ

    Product Label
  • INGREDIENTS AND APPEARANCE
    GRANDMA ELS 
    diaper rash ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52248-200
    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:52248-200-4156.7 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52248-200-42106.3 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:52248-200-431.75 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2015
    Labeler - MEADOWBROOK LABS, INC. (799274183)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABBE Laboratories, Inc.781745286manufacture(52248-200)
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