Label: PURE PETROLEUM COCONUT SCENTED- white petroleum 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 August 13, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP (99.9 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For the temporary protection of minor cuts, scrapes, burns and sunburn.

    • Helps to temporarily protect chafed, chapped, cracked  or windburned skin and lips.
  • WARNINGS

    Warnings

    For External Use Only.

    Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask doctor if conditon worsens or does not improve within 7 days.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Pure Petroleum Coconut Scented Jelly

    Net Wt. 4 oz. (113g)

    label

  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM   COCONUT SCENTED
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-128-35100 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:52920-128-36113 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:52920-128-37170 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:52920-128-38226 g in 1 JAR; Type 0: Not a Combination Product
    5NDC:52920-128-39283 g in 1 JAR; Type 0: Not a Combination Product
    6NDC:52920-128-40368 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/10/2015
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-128)
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