Label: GRANDMA ELS- diaper rash ointment ointment

  • 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, 2014

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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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