Label: TENZER BABY- petrolatum jelly

  • 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 September 5, 2014

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  • Drug Facts

  • Active ingredient

    Petrolatum USP 99.7%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor
      • cuts, scraps, burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind & cold weather
  • Warnings

    • For external use only

    When using this product

    • do not get into eyes

    See a doctor

    • if condition lasts more than 7 days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

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

  • Directions

    • apply as needed
  • Inactive ingredient

    fragrance

  • SPL UNCLASSIFIED SECTION

    Distributed By :
    Collection 2000 Cosmetics Inc.
    Miami, Florida - 33126. USA.

  • PRINCIPAL DISPLAY PANEL - 284 g Container Label

    TENZER™

    Petroleum Jelly
    with fragrance

    1
    2   3

    NET WT 10 Oz [284g]

    PRINCIPAL DISPLAY PANEL - 284 g Container Label
  • INGREDIENTS AND APPEARANCE
    TENZER   BABY
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69174-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.7 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69174-125-10284 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:69174-125-13368 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/30/2012
    Labeler - Collection 2000 (809478688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vikshara Trading & Investments Ltd.675920690MANUFACTURE(69174-125)
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